#Food Safety Testing Market Reports

[ananya5400]

The food pathogen safety testing equipment and supplies market is experiencing significant global growth due to growing concerns about food safety and its impact on consumer health. Stricter regulations and high-profile foodborne illness outbreaks have increased public awareness, driving the demand for advanced testing solutions.

[supriyab]

The food pathogen safety testing equipment and supplies market is estimated to be valued at USD 7.4 billion in 2023 and is projected to reach USD 10.4 billion by 2028, at a CAGR of 7.1% from 2023 to 2028.

[foodagriculturenews]

The food pathogen testing market size is predicted to grow at a CAGR of 8.4% between 2023 and 2028, reaching a value of $22.7 billion by 2028 from a projection of $15.1 billion in 2023.

[killed-by-choice]

“Sadie Roe,” 24 (USA 2013)

“Sadie” died after undergoing a chemical abortion. Her death was counted in the FDA Adverse Event Summary for the mifepristone/misoprostol abortion regimen, but despite investigation, it is still unknown which of her complications caused her death.

Sadie was 24 and had no known health problems. On or about August 15, 2013, she underwent the abortion. She began to feel sick afterwards and went to a doctor, who prescribed an antibiotic. It is unknown what kind of infection the doctor had diagnosed.

On August 20, someone found Sadie’s dead body. An autopsy was conducted to try to find out how a young woman went from healthy to dead in five days.

The autopsy results came back with a mystery. Although traces of cannabinoids and ibuprofen (most likely Sadie’s attempt to treat her pain) were detected, both were so inconsequential that the toxicology report cleared her as negative. Neither drug was in a concentration that could have killed her. Many people had already died of sepsis caused by Clostridium bacteria, so tissue samples were sent to the CDC for testing. The samples came back negative for the species tested.

However, several life-threatening problems were found at Sadie’s autopsy. She had retained part of the placenta from the abortion, which is a serious complication that risks infection. Her organs were damaged; she suffered ���acute visceral and pulmonary congestion and edema.” Microbiology testing had come back negative for the Clostridium strain that had been investigated, but after less than a day the cultures grew streptococcus viridans.

So which of these killed Sadie? The coroner initially listed “unspecified natural causes,” but the CDC analyzed her case and tried to determine what the cause of death was. They finally concluded that the cause of death was undetermined, but included her in the count of pregnant people who died after chemical abortion.

Years later, six doctors reviewed Sadie’s case. They found the confirmation of retained placenta, her symptoms and the Streptococcal species in her lab cultures to be indicative of sepsis and Acute Respiratory Distress Syndrome. Viridans group streptococci can cause life-threatening infections and had been reported to have antibiotic-resistant strains, so this is also consistent with the Azithromycin prescription.

While we still do not have a definite answer on the precise cause of Sadie’s death (and sadly, we may never be sure), it can be assumed beyond reasonable doubt that side effects of the abortion played a highly significant role.

Individual Case Safety Report number 9587011-03-00-01, Danco Laboratories, LLC. Office of Post-marketing Drug Risk Assessment, Food and Drug Administration.

https://www.fda.gov/media/154941/download

[mariacallous]

"I’m going to let him go wild on health,” former president Donald Trump said of Robert F. Kennedy Jr. at his Madison Square Garden rally in New York City this past weekend. “I’m going to let him go wild on the food. I’m going to let him go wild on the medicines.”

Kennedy, a former Democrat, suspended his presidential campaign in August and endorsed Trump. He has since launched the Make America Healthy Again campaign, an initiative focused on tackling chronic diseases that Trump has seemingly embraced in recent weeks. Given Kennedy’s anti-vaccination stance and conspiratorial leanings, some policy experts and former government officials are concerned about how his views could shape the nation’s health agenda.

Kennedy has long made false statements about the safety of vaccines and has touted disproven treatments for Covid-19, including ivermectin and hydroxychloroquine. On the campaign trail, he has railed against seed oils, blaming several chronic health conditions on their presence in processed foods.

How much influence Kennedy could have on national health policy will all depend on his role within a future Trump administration. Trump did not clarify his remarks at Sunday’s event, including what position he is considering Kennedy for. According to a CNN report that ran late Tuesday, Kennedy said Trump “promised him control of the public health agencies,” but in an email to WIRED on Wednesday, Steven Cheung, Trump’s campaign communications director, said that formal discussions of who will serve in a second Trump administration are premature.

Trump could be considering Kennedy to lead the Department of Health and Human Services, which has 80,000 federal employees, or one of the agencies within it, such as the Food and Drug Administration or the Centers for Disease Control and Prevention. It would be a departure from his previous top health picks, who had lengthy government or public health careers. For instance, Alex Azar, Trump’s HHS secretary, was deputy HHS secretary under George W. Bush and an executive at drugmaker Eli Lilly. Scott Gottlieb, a physician and investor appointed as FDA commissioner under Trump, had previously worked for the FDA and had served on the boards of pharma and biotech companies.

When asked to elaborate on Kennedy’s health priorities, Amaryllis Fox Kennedy, the former candidate’s campaign director and daughter-in-law, told WIRED: “Bobby aims to end conflicts and corruption at the agencies, ensure all testing is undertaken by scientists who have no financial interest in the outcome, and all results of all trials are released to the public. The free market will take care of it from there.” (The National Institutes of Health already requires results of clinical trials funded by the agency to be published to a government database.)

Jerome Adams, US surgeon general under Trump and current executive director of health equity initiatives at Purdue University, says that even if Kennedy were tapped to lead HHS, the FDA, or the CDC, it’s unlikely that he would ascend to one of those roles due to his lack of medical training and controversial views on public health issues. “Congressional approval is required for these positions, and his stances could be a barrier,” Adams says.

If Republicans control the Senate after next week’s election, though, that calculus could change. “The GOP has generally fallen into line in terms of supporting candidates that President Trump does,” says Genevieve Kanter, associate professor of public policy at the University of Southern California.

If chosen to be FDA commissioner, Kennedy would control the agency’s budget and priorities and could have a sizable impact by installing lower-level appointees who are sympathetic to his worldview. While the FDA commissioner does not single-handedly approve or authorize new drugs, Kantner says outside political pressure can certainly influence that process. Kennedy could also appoint members to FDA advisory committees, panels of outside experts that make recommendations to the agency on drug approvals and other regulatory matters. The FDA often follows the recommendations of advisory committees when making decisions on new drug approvals, but not always.

The FDA can also choose to not enforce some rules in certain circumstances—what’s known as enforcement discretion. Given his support for dubious and unproven therapies, such as stem cells and hyperbaric oxygen, an FDA under Kennedy, for instance, could choose to not go after companies that market unapproved treatments.

“When we think of the kind of person we want to be head of HHS or be FDA commissioner, someone ‘going wild’ isn’t exactly the first trait that comes to mind,” Kanter says. “It wouldn’t ease the public’s concern that we would see more food safety incidents and adverse events from poorly regulated drugs and devices from a lax administration that is known for embracing unscientific theories.”

Kennedy wouldn’t have free rein though. Existing laws and regulations govern how the agency works, and a new FDA commissioner wouldn’t be able to get rid of those quickly. “If you’re dealing with regulatory issues that have been long-standing and have lots of precedent, it’s just not possible to turn some of those things around or dismiss them overnight,” says a past leader of the FDA, who requested anonymity so that they could speak freely.

Likewise, even in a leadership role at HHS or the CDC, Kennedy wouldn’t be able to easily affect vaccine policy. Vaccine recommendations are made by the Advisory Committee on Immunization Practices, which comprises outside medical and public health experts. Georges Benjamin, executive director of the American Public Health Association, says Kennedy could try to stack that advisory committee with people who are sympathetic to his views on vaccination, but those members are chosen through a rigorous nomination process.

“He could certainly change policy that way, but it takes a while and it won't be a secret. There are ways in which the public can push back, including taking a case to court,” he says.

Kennendy could have influence in other ways beyond direct control of a public health agency. Trump could potentially bring Kennedy on as a White House adviser, which wouldn’t require approval by the Senate.

“Without congressional vetting and oversight, there is potential for unchecked impact. RFK's views could shape health policies, raising concerns about misinformation and harm,” Adams says.

Karoline Leavitt, national press secretary for the Trump campaign, told WIRED in an email that if reelected, Trump will establish a “special Presidential Commission of independent minds and will charge them with investigating what is causing the decades-long increase in chronic illnesses.” She did not say whether Kennedy would be chosen for that task force.

Kennedy has also been sizing himself up for another position in a potential Trump cabinet: agriculture secretary. A longtime environmental activist, Kennedy has promised to take on big farms and feedlots, reduce pesticides, and fix what he presents as a food system captured by corporate interests. “When Donald Trump gets me inside,” Kennedy said in a video shot outside the Department of Agriculture headquarters in Washington, DC, “it won’t be that way any more.”

This platform is a continuation of Kennedy’s long history as an antagonist against the agriculture industry. In 2018, Kennedy and a team of attorneys won an initial $289 million settlement against Monsanto, representing a groundskeeper who developed cancer after being soaked with a herbicide made by the agrochemical firm. He also attempted to sue the pig farming company Smithfield because of its production of hog manure, although that case was thrown out by a federal judge.

Kennedy’s past makes him an unlikely candidate for agriculture secretary, according to Daniel Glickman, who served in the role during Bill Clinton’s presidency. “It’s hard for me to imagine, given Trump’s traditional base in the heartlands, that he would pick somebody who was an advocate for breaking up large farms and breaking consolidated agriculture,” says Glickman.

Like top posts at HHS, the USDA secretary position would need to be confirmed by a Senate vote. “I don’t think [Kennedy] is a slam dunk,” says Glickman.

Trump’s pick for USDA chief during his first term was Sonny Perdue, a former governor of Georgia and founder of an agricultural trading company. Most agriculture secretaries either have a background in the industry or politics—two crucial constituencies for the person who will be in charge of a department that employs nearly 100,000 and is made up of 29 agencies, including forestry, conservation, and nutrition programs. “The difference between Sonny Perdue and Robert F. Kennedy, Jr. is like night and day,” says Glickman.

If Kennedy were to be confirmed as agriculture secretary, he might struggle to enact the most radical parts of his program. He is an outspoken critic of pesticides, but the USDA is generally not in charge of regulating those, says Dan Blaustein-Rejto, director of agriculture policy and research at the Breakthrough Institute. Rather, the EPA regulates pesticides with public health uses.

Although he may not be able to directly influence pesticide regulations, Kennedy has said he would try to “weaponize” other agencies against “chemical agriculture” by commissioning scientific research into the effects of pesticides. The USDA Agricultural Research Service has a nearly $2 billion discretionary budget for research into crops, livestocks, nutrition, food safety, and natural resources conservation.

There are other levers that an agriculture secretary could pull, says Blaustein-Rejto. The USDA is investing $3 billion through the partnership for climate-smart commodities—a scheme that’s supposed to make US agriculture more climate-friendly. A USDA chief might be able to put their thumb on their scale by influencing the selection criteria for these kinds of programs. The USDA also oversees the Commodity Credit Corporation (CCC), which has a $5 billion fund that it uses to support farm incomes and conservation programs, and to assist farmers hit by natural disasters. It’s possible that a USDA chief could influence how these CCC funds are distributed by the agency.

Kennedy has also argued that corporate interests have captured the US’s dietary guidelines, and he pledged to remove conflicts of interest from USDA groups that come up with dietary guidelines. US dietary guidelines are developed jointly by the USDA and HHS and are updated every five years, giving the agriculture secretary limited opportunities to influence any recommendations.

“If RFK is in a high-level policy role, I expect to see a lot more talk about ultra-processed foods, but I’m not sure what that would actually entail when it comes to the dietary guidelines,” says Blaustein-Rejto.

The experts WIRED spoke with largely think Kennedy’s more extreme positions will likely be constrained by bureaucracy. But the message that elevating a vocal vaccine skeptic and conspiracy theorist would send remains a serious concern ahead of a potential second Trump administration.

[meret118]

Tainted CPAP machines and ventilators went to children, the elderly and at least 700,000 veterans despite internal warnings. Company insiders said the devices posed an “unacceptable” risk.

The first complaints landed at the offices of Philips Respironics in 2010, soon after the company made a fateful decision to redesign its bestselling breathing machines used in homes and hospitals around the world.To silence the irritating rattle that kept users awake at night, Philips packed the devices with an industrial foam — the same kind used in sofas and mattresses. It quickly became clear that something had gone terribly wrong.

The reports coming into Philips described “black particles” or “dirt and dust” inside machines that pump air to those who struggle to breathe. One noted an “oily-like” substance. Others simply warned of “contamination.”

Yet Philips withheld the vast majority of the warnings from the Food and Drug Administration, even as their numbers grew from dozens to hundreds to thousands and became more alarming each year.

. . .

Instead, as the complaints continued to pile up in company files, Philips waged aggressive global marketing campaigns to sell more machines, including new models fitted with the hazardous foam.The sales pitch worked: The devices went to infants, the elderly and at least 700,000 veterans. The company also promoted machines meant for some of the sickest people in the country, rolling out a new ventilator filled with the foam in the early months of the COVID-19 pandemic.

. . .

All the while, people using Philips machines were suffering from illnesses that no one could explain: vomiting, dizziness and headaches, along with newly diagnosed cancers of the lungs, throat, sinuses and esophagus. One man in Philadelphia coughed so hard that he broke his ribs, and a Florida woman with a hacking cough was hospitalized for days and placed on oxygen.

. . .

Studies published in scholarly journals showed the foam broke apart in heat and moisture. The company used it anyway, even though the machines send air for hours at a time into the lungs of users.

. . .

As news of the problem spread, customers and others stepped forward by the thousands, describing emergency room visits and sudden illnesses in reports submitted to Philips and the government. The reports detailed nearly 2,000 cases of cancer, 600 liver and kidney illnesses and 17,000 respiratory ailments.

. . .

The company acknowledges that the foam tested positive for genotoxicity — its own experts described “uncontrolled cellular replication” — but said that a third-party assessment still concluded the machines are unlikely to cause harm.

The three experts consulted by the news organizations said that’s not possible. While safety thresholds for chemical emissions vary and findings can be open to interpretation, genotoxicity means that one or more chemicals are changing cells, the building blocks of the human body.

“You can’t make the argument that it’s safe. That’s bad science,” said the engineer familiar with the Philips testing. “It’s a real-life failure that shows you have a problem. There’s no ambiguity. There is unacceptable risk. Full stop.”

The company’s ventilators also tested positive for genotoxicity; Philips said the devices are still being assessed.

. . .

More details about the health risks are expected to emerge through the ongoing federal lawsuits in Pittsburgh. Earlier this month, the company reached a settlement in one of the cases, agreeing to pay at least $479 million to reimburse customers and others for the costs of the defective machines.

Other legal challenges are still ongoing, including more than 600 personal injury claims and a class-action suit seeking ongoing medical monitoring and research on the dangers posed by the devices.

------

They knew the foam would break down when they decided to use it. Tests within the company after complaints came in showed how dangerous the devices were, but they refused to even change the design for new sales, much less recall the old ones. For every official complaint, how many more people were harmed that weren't reported?

They didn't recall them until 3,700 official complaints had been made. Until after they sold over 5 million life-threatening machines. There's no way to know how many people they killed.

If they think the products are so great, then they won't mind being forced to use them.

Companies will keep doing this until the financial cost of hurting people is greater than the profits from doing so.

Trigger warning for disturbing medical details, descriptions of suffering, and an image of a permanent feeding tube, in the article.

[coraltragedywinner]

10 Things You Learned in Preschool That'll Help You With strongest edibles

Indicators on Cannabis & Cbd Edibles You Should Know

Table of ContentsGetting My Cbd Oil: 9 Science-backed Benefits To WorkSome Known Factual Statements About Cbd: Safe And Effective? The smart Trick of What Are The Benefits Of Cbd? That Nobody is Discussing10 Best Cbd Gummies Of 2022 Can Be Fun For EveryoneWhat Are Cbd Gummies? Are There Any Health Benefits? - The Facts

Along with appreciation to items labeled to have "hemp" that may also consist of THC or CBD, as discussed over it is actually a banned process under section 301( ll) of the FD&C Process to introduce or provide for introduction in to interstate commerce any type of fodder to which THC or even CBD has been incorporated. cost of edibles.

Articles from Marijuana and Cannabinoid Study are supplied here courtesy of

Cannabidiol (CBD) is actually commonly dealt with in the media, as well as you might see it proclaimed as an add-in booster to your post-workout shake or early morning coffee. You can easily even buy a CBD-infused sporting activities bra. vitamins for stoners. But exactly what is actually CBD? As well as why is it thus prominent? CBD, or even cannabidiol, is actually the second most rampant energetic substance in cannabis (cannabis).

Presently, many individuals acquire CBD online without a health care cannabis license, which is legal in most states. edible strength. CBD has actually been actually proclaimed for a broad range of health problems, yet the greatest medical evidence is actually for its performance in dealing with several of the cruelest childhood years epilepsy disorders, including Dravet syndrome and also Lennox-Gastaut syndrome (LGS), which usually don't react to antiseizure medicines (edible strengths).

Rumored Buzz on Cannabis & Cbd Edibles

Epidiolex, which has CBD, is actually the very first cannabis-derived medicine permitted by the FDA for these health conditions. Pet researches, and self-reports or investigation in people, recommend CBD may likewise assist with: Research studies and scientific tests are actually exploring the usual record that CBD may lessen stress and anxiety. Researches advise that CBD might assist with both going to sleep and remaining asleep.

Therefore, you must allow your doctor understand if you are regularly utilizing CBD. A considerable security worry about CBD is actually that it is actually largely industried and also marketed as a supplement, not a medication. Currently, the FDA performs not control the safety and also purity of diet supplements. So, you can certainly not make sure that the product you acquire possesses energetic components at the dose noted on the tag - healthy edibles.

Outside of the US, the prescription medicine Sativex, which utilizes CBD as an energetic substance, is actually permitted for muscle spasticity connected with numerous sclerosis and for cancer discomfort (edibles cost). Within the United States, Epidiolex is approved for certain kinds of epilepsy and also tuberous sclerosis. Some CBD suppliers have actually come under federal government analysis for crazy, indefensible cases, such that CBD is actually a cure-all for cancer or COVID-19, which it is actually certainly not.

If we integrate this details along with your secured health and wellness relevant information, we will definitely address all of that relevant information as protected health and wellness info as well as are going to only utilize or even make known that relevant information as specified forth in our notice of personal privacy techniques. You may opt-out of email interactions any time through selecting the unsubscribe web link in the email (how to recover from edibles).

The Definitive Guide for Analysis Of “Marijuana Edibles” – Food Products Containing

Cannabis consists of over 113 various chemical materials called cannabinoids. Cannabidiol (CBD) and also delta-9-tetrahydrocannabinol (THC) are 2 sorts of chemical compounds originated from cannabis (can you mail edibles). Over the last few years, welfare has increased in the prospective health effects and also perks of marijuana. Much of this passion has focused on these 2 cannabinoids. This passion is going to likely develop as cannabis as well as marijuana items become legal in additional conditions.

THC is commonly conducted by cigarette smoking cannabis, but it can easily likewise be actually discovered as an element in pills, edibles, as well as oils. strongest edibles. THC and CBD have an effect on the endocannabinoid body, an unit that participates in a vital function in sustaining homeostasis. Scientists are actually still operating to know the details of this complex system, but they carry out know that it is actually linked with methods featuring mind, hunger, sleep, state of mind, and productivity.

THC Psychedelic (makes a higher) Sourced from weed CBD Non-psychoactive (does not create a high) Commonly sourced coming from hemp CBD and also THC influence different receptors in the brain (healthy edibles). Considering that of this, CBD usually performs certainly not possess psychoactive effectsin other phrases, it won't create you to receive higher. THC, however, performs have psychoactive results.

By mimicking endocannabinoids, they bind along with receptors and also trigger various results in the body system. While CBD may arise from either hemp or weed, it is typically acquired from hemp to avoid the enhancement of much larger quantities of THC. THC, on the various other palm, is stemmed from cannabis. CBD that arises from cannabis may include additional THC, which might certainly not be perfect for folks that are actually attempting to stay away from THC (vegan edibles).

Getting My Medical Marijuana 'Edibles' Mostly Mislabeled, Study Shows To Work

However, CBD can easily help lower swelling, which works for lasting effectiveness. Some evidence suggests that taking both CBD and also THC might deliver the best discomfort comfort. In one study, folks who took a mix of CBD as well as THC experienced more significant ache relief than those who took THC alone. While marijuana on its own has actually not been FDA permitted to deal with any disorder, there are a couple of medicines accepted due to the USA

Research additionally recommends that weed can easily modify mind advancement and also might lead to intellectual issue - edibles prices. NIDA likewise keeps in mind that THC alters just how the hippocampus as well as orbitofrontal cortex function. These regions of the human brain are vital in the buildup of brand-new minds and also the capability to change interest from something to the following.

When picking CBD or even THC products, it is likewise crucial to consider their validity. Each marijuana and THC are featured in the united state Controlled Substances Action, which indicates that they are actually illegal under government law. Since July 2020, 33 conditions as well as Washington, D.C. have actually passed policies enabling clinical weed and products consisting of THC to be actually suggested through a physician.

Although CBD in certain forms is actually lawful in many conditions, the specifics of the legality of any type of THC or CBD item can differ from one state to the next. A number of states have likewise approved using cannabis and also THC for leisure objectives. Given that the regulations pertaining to using marijuana and also marijuana items are actually quickly changing, you must always check your condition's rules prior to using items consisting of CBD or even THC.

Not known Factual Statements About The Trouble With Cbd Oil

It is important to keep in mind that the impacts of these topical items will be local because they are certainly not being taken in. CBD can easily additionally be taken orally as a cast, oil, capsule, or even spray. Edible CBD products are actually likewise well-known and consist of gummies, sweets, as well as drinks. When selecting CBD items, it is actually also necessary to https://app.gumroad.com/ceallaxplh/p/10-great-fresh-bros-public-speakers-e06dc306-8866-4889-a23e-59b41e9d6f85 consider its solution.

Broad-spectrum products contain other cannabinoids except THC, while full-spectrum CBD products consist of CBD, THC, as well as other cannabinoids. The item you pick might depend on the effects you are actually trying to attain - vitamins for stoners. If you are attempting to decrease anxiety or even sleep much better, as an example, CBD might give perks without the unfavorable negative effects affiliated with THC.

Some study proposes that the prospective curative effects of THC and CBD tend to become higher when the two cannabinoids are gotten together all at once. vitamins for stoners. This sensation is actually known as the entourage result. Taking CBD in addition to THC has likewise been actually shown to help in reducing some of the unnecessary impacts that THC may have.

[ausetkmt]

Food Poisoning Bulletin: Consumer Reports Finds Lead and Cadmium in Dark Chocolate

Food Poisoning Bulletin: Consumer Reports Finds Lead and Cadmium in Dark Chocolate.

Consumer Reports has found high levels of lead and cadmium in some dark chocolate candy brands. A study conducted by As You Sow found that many popular brands contain alarming levels of those heavy metals.

Consumer Reports Finds Lead and Cadmium in Dark Chocolate

Most people believe that dark chocolate is healthier than milk chocolate. And it may improve heart health. But this information may make some people rethink that assumption. Lead can cause significant health problems, including cancer, and it can reduce IQ and cause learning disabilities in children. Cadmium causes damage to reproductive organs, and can also damage the liver, kidneys, and bones.

As You Sow has filed legal notices with more than 20 companies that make these dark chocolate candies, including Hershey’s, Trader Joe’s, Lindt, Whole Foods, Kroger, Godiva, See’s Candies, Mars, Equal Exchange, Ghirardelli, Chocolove, and Kroger.

Consumer Reports found heavy metals in all 28 dark chocolate bars that they tested. For 23 of those chocolate bars, eating just one ounce a day would put an adult over a level that public health officials say could be harmful. Five of the bars were above the levels for both radium and lead.

The problem is that cacao plants take up cadmium from the soil when they grow. Lead contaminates the cocoa beans after they are harvested. When the beans were picked and removed from pods, the lead levels decreased, but when they were dried in the sun, they were re-contaminated.

Tunde Akinleye, the Consumer Reports food safety researcher who led this testing project said inn a statement, “While most people don’t eat chocolate every day, 15 percent do, according to the market research firm Mintel. Even if you aren’t a frequent consumer of chocolate, lead and cadmium can still be a concern.” Akinleye adds that because some companies can make bars without those high levels of heavy metals, they can do more of it.

The chocolate bars that were high in both lead and cadmium were Trader Joe’s The Dark Chocolate Lover’s Chocolate with 85% Cacao, Theo Organic Pure Dark 70% Cocoa, Theo Organic Extra Dark Pure Dark Chocolate 85% Cocoa, Lily’s Extremely Dark Chocolate 85% Cocoa, and Green & Black’s Organic Dark Chocolate 70% Cacao.

Chocolates such as Dove Promises Deeper Dark Chocolate 70% Cocoa were high in cadmium, while Godiva Signature Dark Chocolate 72% Cocoa was high in lead. You can see all of the tested chocolates and the results on the Consumer Reports site.

The safer choices include Mast Organic Dark Chocolate 80% Cocoa, Ghirardelli Intense Dark Chocolate 86% Cacao, and Valrhona Abinao Dark Chocolate 85% Cacao, among others.

[ananya5400]

Food Pathogen Safety Testing Equipment and Supplies Market Growth by Emerging Trends, Analysis, & Forecast

The food pathogen safety testing equipment and supplies market is estimated to be valued at USD 7.4 billion in 2023 and is projected to reach USD 10.4 billion by 2028, at a CAGR of 7.1% from 2023 to 2028. The food pathogen safety testing equipment and supplies market is experiencing significant global growth due to growing concerns about food safety and its impact on consumer health. Stricter regulations and high-profile foodborne illness outbreaks have increased public awareness, driving the demand for advanced testing solutions. The European region's food industry, known for its strict food safety regulations, demands robust testing procedures to maintain the integrity of its food supply chain. As the food industry expands, the risk of contamination increases, prompting food manufacturers and suppliers to invest in advanced testing technologies. Advancements in testing technology, such as PCR and NGS, have revolutionized the field of food pathogen safety testing, enabling rapid and accurate detection of pathogens. Consumer awareness and demand for safe food products are driving market growth in Europe, with consumers willing to pay a premium for products with higher safety standards. Supportive government initiatives, financial backing, and infrastructure upgrades encourage businesses to adopt modern testing methodologies, leading to market expansion.

Download PDF Brochure:  https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=211750412

Based on food tested, the meat & poultry sub-segment is estimated to account for the largest market share of the food pathogen safety testing equipment and supplies market.

The meat & poultry segment has established its dominance in the food pathogen safety testing equipment and supplies market. This prominent position can be attributed to the unique characteristics of meat and poultry products, which make them highly susceptible to pathogen contamination. Their high protein content and moisture levels create an optimal environment for microbial growth, necessitating stringent testing measures to ensure consumer safety.

Due to the significant contribution of meat and poultry to the global food industry and the substantial consumption volumes, the demand for specialized equipment and supplies for pathogen testing remains consistently high. Stringent food safety regulations and the increasing focus of consumers on the quality and safety of food products further bolster the need for thorough testing in this segment. Regular pathogen testing not only prevents potential outbreaks and foodborne illnesses but also protects the reputation of food producers and maintains consumer confidence in the safety of meat and poultry products.

Based on site, the outsourcing facilities sub-segment is anticipated to dominate as well as grow at the highest CAGR in the food pathogen safety testing equipment and supplies market.

Food producers are increasingly requesting rapid testing technology to speed up results and speed up supply chain operations. Additionally, compared to conventional technology, quick procedures have improved accuracy, sensitivity, and the capacity to test a wide range of pollutants while concurrently generating accurate results. For instance, a new technology that can create and instantly dispense culture media for use in microbiological food testing was introduced by Millipore Sigma, a US, and Canadian-based Life Science business unit of the chemical corporation Merck KGaA, in April 2022. The newly developed technology, known as the ReadyStream system, offers producers increased testing effectiveness and does away with the standard microbiological testing process' five steps.

Request Sample Pages: https://www.marketsandmarkets.com/requestsampleNew.asp?id=211750412

Asia Pacific is estimated to grow at the highest CAGR in the food pathogen safety testing equipment and supplies market.

With the region’s vast population, rapid urbanization, and increasing disposable incomes, there is a growing demand for safe and high-quality food products, prompting the food industry to invest in advanced pathogen safety testing equipment to comply with stringent regulations and ensure consumer trust. Additionally, Asia Pacific countries have been actively working to strengthen their food safety standards, fostering the adoption of advanced testing technologies. The thriving food and beverage industry in the region further fuels the demand for efficient testing methods to monitor and control potential contaminants. Technological advancements and international collaborations have also facilitated the development and dissemination of innovative and cost-effective testing solutions in the region.

[omcmedicalblog]

South Korea Medical Device Regulation - OMC Medical Limited

Regulatory Authority

The Ministry of Food and Drug Safety (MFDS)

The Korea Medical Devices Industry Association (KMDIA), the largest association of over 900 medical devices companies, aims to improve public health and boost industry growth by partnering with its members to lead technological advances in the 21st century.

Link for Regulatory Authority

Local Regulation

Medical Device Act (MDA)

Classification of Medical Devices

Medical Devices: Class I, II, III and IV

IVDs: Class I, II, III and IV

Overview of Notification, Certification and Approval Process in Medical Devices

MFDS requires the submission of ‘Technical Documents’ for the certification and approval of medical devices. In principle, Class I & II devices are certified by Medical Device Information and Technology Assistance Center (MDITAC) the National Institute of Medical Device Safety Information (NIDS) and Class III & IV devices are approved by MFDS. However, Class I & II devices in the categories below must be approved by MFDS.

which require clinical test reports

Digital Healthcare related (ex. telemedicine system)

Undefined Nomenclature & classification regulation

Combined with pharmaceuticals, etc.

Listing or Registration Requirements

Classify the medical device

Appoint an Authorized Korean License holder

Apply for KGMP Certification 4. Submit Certification/ Approval

MFDS requires those who intend to produce a medical device in Korea, or who intend to import a medical device from overseas to obtain a manufacturing business license and an import business license, respectively.

Documents Required for South Korea Medical Device Registration

Technical Documents

Documents related to quality of medical devices, such as performance and safety, etc.

Which include information on ‘Intended Use,’ ‘Mechanism of action (MoA),’ ‘Operational (Functional) Structure,’ ‘Raw Materials,’ ‘Instruction for Use,’ ‘Test Specifications,’ etc.

Technical Document Classification

The technical documents consist of ‘Application Form’ and ‘Supplementary Evidence.’ The presence of mandatory submission of ‘clinical trial reports’ (as a part of ‘Supplementary Evidence’) determines application procedure to be followed.

General Technical Document Review

If a device is substantially equivalent to legally marketed devices, ‘clinical trial reports’ are not required.

Safety and Efficacy Review (SER)

The technical document including ‘clinical trial reports’ is thoroughly reviewed

‘Clinical trial reports’ are required if differences such as ‘Intended Use,’ ‘Mechanism of Action (MoA)’ and ‘Raw Materials’ could significantly affect safety and efficacy of devices

Premarket Approval

Class I (Notification)

Class II (Certification, Approval)

Class III, IV (Approval)

Premarket Approval Process:

MDITAC

Class I Approval Process: Notification

Application for notification

QMS requirements

Class II Approval Process: Certification

Application for certification

QMS requirements

Timeline: Certification – 5 days

NIFDS

Class II, III and IV Approval Process: Approval

Technical Document Review

QMS Requirements

Timeline:

Technical Document: 55 days

Clinical trial: 75 days

Certification of Class II Medical Devices

“SE Device” is a medical device (or an IVD) that is equivalent in ‘Intended Use,’ ‘Mechanism of Action (MoA),’ ‘Raw Materials, ‘Performance,’ ’Test Specification’ (not applicable to IVD), ‘Instructions for Use’ (not applicable to IVD) with previously approved/certified/notified medical devices. ※ For medical devices in Class II that were approved and certified for more than three times with the equivalent product, MFDS may officially announce those as a ‘Recognized Substantial Equivalent (SE) devices’

“Modified Device” is a medical device(or an IVD) that is equivalent in ‘Intended Use’, ‘Mechanism of Action(MoA)’, ‘Raw Materials(Limited to implanted/contacted devices & most of devices are not intended to operate electrically, not applicable to IVD)’ with previously approved/certified/notified medical devices, but not equivalent in ‘Raw Materials’(only applicable to IVD) ‘Performance’, ’Test Specification’ (not applicable to IVD), ‘Instructions for Use’ (not applicable to IVD).

Approval of Class II, III and IV Medical Devices

NIFDS (affiliated agency of MFDS) approves ‘New devices (Class II)’ and ‘Class III and IV Devices’

Class II, III and IV devices must submit:

Technical File

S&EP Data

Clinical Trial Reports

Test Reports

IFUs, Labelling

Registration Timeline

Class I (NIDS) – 1 Month

Class II(NIDS)- 3-5 months

Class III- 9 months

Class IV – 9-12 months

Registration Fee

Class I: ₩85,000 (approx. US$73).

Class II:

PMA with SER: ₩130,000 (approx. US$112).

PMA without SER: ₩1,495,000 (approx. US$1,283)

SPMA: ₩130,000 (approx. US$112)

Class III & IV:

With SER: ₩719,000 (approx. US$617)

Without SER: ₩1,495,000 (approx. US$1,283)

SER- (registered predicate or Substantial Equivalent (S.E.) exists in Korea.)

License Validity and Renewal

Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.

Special Labelling Requirements

Label and instructions for use must be provided in Korean

Additional Comments

All application files must be available in Korean language

Who should make this Communication?

Manufacturer

Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the Process?

Act as your Authorized representative

Why Choose Us?

Working towards client satisfaction

Cost effective solutions

Project completion before deadline

Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk

Originally Published at: https://omcmedical.com/south-korea-medical-device-registration/

[vicky12233]

The Essential Role of Environmental Stability Test Chambers in Quality Assurance

Introduction

In today's competitive manufacturing landscape, ensuring product quality and reliability is paramount. This is especially critical in industries such as pharmaceuticals, electronics, automotive, and aerospace, where environmental conditions can have a significant impact on product performance. Environmental Stability Test Chambers supplier (ESTCs) play a crucial role in simulating real-world conditions to evaluate the endurance of materials, products, and components. Suppliers of these test chambers help manufacturers achieve the necessary standards, certifications, and insights to deliver superior products to the market.

What is an Environmental Stability Test Chamber?

An Environmental Stability Test Chamber is a laboratory device used to simulate various environmental conditions such as temperature, humidity, and pressure. These chambers are designed to test the performance and reliability of products under extreme or fluctuating environmental conditions that they may encounter during their life cycle. ESTCs are used in a variety of industries, including pharmaceuticals, biotechnology, food processing, automotive, electronics, and materials science.

These chambers typically feature advanced technology to replicate conditions such as high/low temperatures, humidity cycles, UV radiation, or even combined temperature and humidity stress. By subjecting products to controlled environmental changes, manufacturers can assess their durability, stability, and overall performance.

Visit Also:- Understanding Stability Chambers: Essential Tools for Environmental Testing

Key Features of Environmental Stability Test Chambers

Temperature and Humidity Control: The core function of any environmental test chamber is the ability to precisely control temperature and humidity. Suppliers typically offer chambers with a wide range of temperature settings, from ultra-low to high-temperature conditions. Humidity levels can also be varied to simulate conditions from dry heat to highly humid environments.

Customizable Programming: Advanced ESTCs come equipped with programmable controls, enabling manufacturers to design specific testing profiles. This flexibility allows for testing under a wide variety of conditions, from short-term stress tests to long-term stability studies.

Data Logging and Monitoring: High-quality test chambers include data logging systems that track and record environmental conditions and test parameters in real time. This feature is essential for maintaining accurate records, ensuring test accuracy, and providing the data required for regulatory compliance.

Uniform Temperature Distribution: Ensuring uniform temperature and humidity distribution within the chamber is essential for accurate testing. Top suppliers offer models that ensure consistency and reliability across all areas of the chamber, preventing any localized discrepancies that could impact results.

User-Friendly Interface: The best environmental stability test chambers feature intuitive interfaces, often with touch screen controls, for easy operation and setup. Users can set and adjust parameters without difficulty, while also accessing test data and reports.

Energy Efficiency: With the increasing focus on sustainability, modern test chambers are designed to be energy-efficient, reducing operating costs and environmental impact while maintaining high performance.

Applications of Environmental Stability Test Chambers

Pharmaceutical and Biotechnology Industries: In these sectors, environmental stability testing is essential to ensure the safety and efficacy of drugs, vaccines, and biologics. ESTCs are used to simulate storage conditions and shelf-life testing under various temperature and humidity conditions.

Electronics Industry: Electronics, including semiconductors and consumer devices, are sensitive to environmental changes. Testing in environmental stability chambers helps ensure that these products can withstand temperature fluctuations, humidity, and other environmental factors without performance degradation.

Automotive Industry: Automobiles are exposed to diverse environmental conditions during their lifecycle. From extreme cold to intense heat and humidity, environmental stability test chambers are used to test components such as batteries, tires, electronics, and interior materials.

Food Industry: Packaging, shelf-life, and product integrity in food manufacturing are critical. ESTCs are used to simulate storage conditions and ensure that food products can withstand changes in temperature and humidity without compromising quality or safety.

Aerospace and Defense: Products and materials used in aerospace and defense applications are subjected to extreme conditions during operation. Stability testing ensures that components will perform under high stress, temperature extremes, and fluctuating atmospheric pressures.

Benefits of Environmental Stability Test Chambers

Ensuring Product Reliability: By simulating real-world conditions, ESTCs help manufacturers identify potential weaknesses in their products before they are released to the market. This leads to improved product reliability and fewer defects or failures in the field.

Regulatory Compliance: Industries like pharmaceuticals and electronics are subject to strict regulatory requirements. Environmental stability testing helps manufacturers comply with these regulations, providing documented evidence that their products meet required standards.

Quality Control and Improvement: Regular testing of products under varying environmental conditions enhances the overall quality control process, allowing manufacturers to refine product designs, materials, and processes for better performance.

Reducing Product Recalls: By identifying flaws early in the testing phase, manufacturers can prevent costly recalls and damage to their brand reputation. This also minimizes the risk of customer dissatisfaction due to product failure.

Cost Efficiency: Environmental stability chambers can reduce the need for expensive real-world testing or prototype testing in natural environments. They provide a faster, controlled, and repeatable testing process, ultimately saving money for manufacturers.

Choosing the Right Environmental Stability Test Chamber Supplier

Selecting the right supplier for Environmental Stability Test Chambers is critical for achieving accurate and reliable results. Here are a few factors to consider when making your choice:

Reputation and Experience: Look for a supplier with a proven track record of delivering high-quality, reliable chambers. Experience in providing solutions for industries similar to yours is a plus.

Customization Options: The best suppliers offer test chambers that can be customized to meet the specific needs of your testing requirements. Whether it’s temperature ranges, humidity settings, or the inclusion of additional features, customization is key to obtaining accurate test results.

Technical Support and Service: A reliable supplier will offer comprehensive after-sales support, including installation, training, and maintenance services. This ensures that the test chambers perform optimally throughout their lifespan.

Compliance with Standards: Ensure the supplier’s chambers meet industry-specific standards, such as ISO, ASTM, or FDA regulations. Compliance guarantees that the testing equipment will produce valid results and ensure product quality.

Cost and Value: While it’s important to consider the cost of the chamber, the value it provides in terms of accuracy, reliability, and efficiency is far more important. The supplier should offer a balance of quality and cost-effectiveness.

Visit Also:- Revolutionizing Plant Growth with Tissue Culture Chambers

Conclusion

Environmental Stability Test Chambers are indispensable tools for industries that require precise testing of products and materials under controlled environmental conditions. Whether you're testing pharmaceutical products, electronics, or automotive components, these chambers provide valuable insights into product performance and longevity. Selecting the right supplier ensures that manufacturers have access to the best technology, support, and customization options to meet their testing needs. By investing in high-quality Environmental Stability Test Chambers, companies can enhance product reliability, meet regulatory standards, and ultimately provide superior products to the market.

[aakarshanblog]

How Trade Tests Ensure Quality Talent for International Markets

In the world of international recruitment, finding the right talent isn’t just about filling a job—it's about ensuring that candidates have the skills, experience, and professionalism to thrive in demanding work environments abroad. For companies in countries like Malaysia, Qatar, Saudi Arabia, Bahrain, and the UAE, securing skilled employees who can meet specific industry standards is critical. This is where trade tests come into play.

At Aakarshan International Pvt. Ltd., we use trade tests as an essential tool to assess and verify a candidate’s skills before they’re matched with employers. Trade tests help us maintain quality, ensuring that our clients receive only the best-prepared candidates who are fully equipped to succeed in their roles. Here’s a closer look at how trade tests work and why they’re so valuable for international recruitment.

What Are Trade Tests?

A trade test is a practical examination that evaluates a candidate’s skills and knowledge in a specific trade or profession. Unlike a standard interview or written test, a trade test simulates real-world tasks that the candidate will perform on the job. For instance:

Construction Workers might complete tasks such as bricklaying, carpentry, or plastering.

Electricians may be asked to troubleshoot circuits or safely wire electrical systems.

Culinary Staff could demonstrate food preparation techniques, cleanliness, and kitchen safety.

Trade tests are designed to be hands-on, assessing practical skills, technical knowledge, and the ability to work efficiently and accurately. This step is crucial in sectors where specialized skills and certifications are mandatory for workplace safety and efficiency.

Why Trade Tests Matter in International Recruitment

When hiring for international markets, accuracy and reliability are key. Employers abroad rely on recruitment agencies to vet candidates thoroughly and provide only those who meet specific qualifications. A single mistake in recruiting could lead to significant losses for a company and tarnish the reputation of the recruitment agency. According to a 2022 report by the International Labour Organization, 65% of employers in the Middle East emphasized that hiring unqualified candidates led to increased turnover and costly retraining.

At Aakarshan International, trade tests help us uphold our commitment to delivering only the best talent. By testing a candidate’s skills beforehand, we prevent potential mismatches and ensure that clients receive reliable, capable employees ready to perform their roles from day one.

The Trade Test Process at Aakarshan International

To maintain consistency and high standards, Aakarshan International has developed a streamlined process for trade testing. Here’s a look at how it works:

Identifying Job-Specific Requirements: Each job role has unique demands, so we start by identifying the specific skills and competencies that each position requires. For example, an HVAC technician and a chef will need entirely different skill sets. By tailoring trade tests to match job requirements, we ensure that candidates are tested on the precise skills they’ll use.

In-House Testing Facilities: Aakarshan International has in-house facilities for conducting trade tests. This allows us to create a controlled, standardized environment that ensures fair and accurate assessments. Our facilities are equipped with industry-standard tools and equipment to create real-life job scenarios, enabling candidates to demonstrate their skills as they would on the actual job.

Professional Evaluators: Our trade tests are conducted by experienced professionals who have in-depth knowledge of the trade they’re assessing. Evaluators closely observe each candidate’s technique, attention to detail, and adherence to safety standards. Their feedback provides a clear picture of each candidate’s strengths and areas for improvement.

Feedback and Improvement Opportunities: For candidates who may need extra training or support, we provide constructive feedback and the option to re-take trade tests after additional preparation. This not only enhances the candidates' skills but also gives them a better chance at securing international opportunities.

Real-World Examples of Trade Test Success

Consider a recent case where a candidate for an electrician position in Saudi Arabia completed a trade test at Aakarshan International. The test required the candidate to wire a basic circuit, troubleshoot a faulty setup, and demonstrate knowledge of electrical safety regulations. By assessing this candidate’s technical knowledge and problem-solving skills in real time, we could confidently recommend them to the client. Within a month of employment, the client reported that the candidate was able to handle complex tasks independently—a clear indicator of the effectiveness of trade testing.

Statistics underscore the importance of these tests: the National Electrical Contractors Association found that electricians who undergo pre-employment skill assessments are 30% more likely to perform effectively and follow safety guidelines on the job.

Trade Tests as a Tool for Reducing Turnover and Increasing Productivity

Hiring the wrong person for a job is costly, especially for international positions. According to the Society for Human Resource Management (SHRM), replacing an employee can cost up to 50-60% of their annual salary due to expenses related to training, lost productivity, and new recruitment efforts. Trade tests help reduce turnover by ensuring that candidates are well-prepared for the demands of their new roles. By hiring candidates who are genuinely skilled, international employers experience fewer disruptions, higher productivity, and a more positive work environment.

For example, a trade test might reveal that a welder is unfamiliar with certain equipment or safety protocols. By identifying these gaps before hiring, we can prevent potential issues for both the candidate and the employer, reducing turnover and fostering a safer, more efficient workplace.

Building Trust with International Clients Through Trade Testing

For global clients, knowing that their recruitment partner has a rigorous screening process builds confidence. When companies work with Aakarshan International, they can trust that our candidates have been tested, vetted, and verified. In an international recruitment environment where trust is essential, trade tests reinforce our commitment to quality, transparency, and professionalism.

Our clients from countries like the UAE and Malaysia often highlight that trade testing gives them peace of mind. They know that their new hires are skilled, reliable, and ready to contribute, which strengthens our client relationships and reinforces our reputation as a trustworthy recruitment agency.

Enhancing Candidate Confidence and Job Satisfaction

For candidates, trade tests serve as more than just a hurdle to clear—they’re a confidence booster. Passing a trade test assures candidates that they have the skills needed to succeed in a foreign job market. This confidence translates into better performance on the job, as they feel equipped and ready to handle the challenges they may face. Furthermore, candidates who pass trade tests have a higher chance of feeling satisfied with their work, as they’re less likely to struggle with unfamiliar tasks or lack the necessary skills.

The University of Cambridge’s 2023 Employment Research Study showed that employees who pass skill-specific assessments report 25% higher job satisfaction rates and demonstrate greater commitment to their roles. By giving candidates a chance to prove their skills before placement, we set them up for a smoother transition into their new work environment.

The Future of Trade Testing in Recruitment

As industries evolve and new technologies emerge, trade testing remains a cornerstone of quality recruitment. In the coming years, Aakarshan International plans to integrate digital solutions into trade testing, making it even easier to assess candidates’ skills accurately and efficiently. We are exploring options like virtual simulations for certain skill-based roles, allowing candidates to demonstrate their abilities remotely when necessary.

Studies show that digital assessments, when paired with hands-on tests, enhance candidate performance predictions by up to 20%. By staying ahead of industry trends and incorporating the latest advancements, Aakarshan International is committed to providing clients with an even more robust and future-ready recruitment process.

Final Thoughts

Trade testing is a powerful tool that enables Aakarshan International to maintain the highest standards in international recruitment. By accurately evaluating candidates’ skills, trade tests ensure that our clients receive reliable, competent employees who are ready to contribute from day one. For candidates, trade tests offer an opportunity to showcase their expertise and gain confidence, making their transition to international roles smoother and more successful.

At Aakarshan International Pvt. Ltd., we believe that trade tests are not just a step in the recruitment process—they’re a cornerstone of quality, trust, and long-term success for both our clients and candidates. As we look to the future, we’re excited to continue raising the bar in recruitment standards, ensuring that quality talent meets quality employers worldwide.

[latestmarketresearchreportsblog]

Medical Device Validation and Verification Market anticipated rise: Expected to reach USD 14.8 billion by 2030 from USD 10.8 billion in 2023

Medical Device Validation and Verification Market: Growth, Trends, and Forecast (2024 - 2030)

The global medical device validation and verification market is witnessing significant growth. From a valuation of USD 10.8 billion in 2023, it is projected to expand at a compound annual growth rate (CAGR) of 4.7%, reaching USD 14.8 billion by 2030. This growth is driven by increasing regulatory pressure, the rising demand for medical devices, and the growing need for safety and reliability in healthcare equipment.

What is Medical Device Validation and Verification?

Medical device validation and verification refer to the processes by which manufacturers ensure that their products meet the required standards for performance, safety, and quality before they are released to the market. Validation involves confirming that a device is designed and manufactured to meet its intended use, while verification focuses on ensuring that it meets specific design specifications. Both processes are critical in ensuring that medical devices are safe for patient use and comply with regulatory requirements.

Get Sample Copy of this Report @ https://intentmarketresearch.com/request-sample/medical-device-validation-and-verification-market-3047.html

Key Drivers of Growth in the Medical Device Validation and Verification Market

Several factors contribute to the rapid expansion of the medical device validation and verification market:

1. Stringent Regulatory Requirements

One of the main factors driving the market is the increasing number of regulatory requirements for medical device approval across regions. Regulatory bodies such as the FDA (Food and Drug Administration) in the United States, the European Medicines Agency (EMA) in Europe, and other international health authorities are imposing more stringent requirements to ensure that medical devices meet safety and efficacy standards. As these regulations become more complex, the demand for validation and verification services is growing.

2. Rising Demand for Medical Devices

With the rise in global health concerns, there has been a significant increase in the demand for medical devices, from diagnostic equipment to surgical instruments and implants. As the healthcare industry continues to expand, the need for devices that are both effective and safe has never been greater. Validation and verification services are essential in ensuring that these devices meet the required standards.

3. Advancements in Medical Technologies

Technological advancements in medical devices are leading to the development of more complex and innovative products. As devices become more sophisticated, the importance of validation and verification becomes even more critical. Ensuring that new medical technologies perform reliably and safely requires thorough testing and verification before they are put into clinical use.

4. Increased Focus on Patient Safety

As healthcare becomes more patient-centric, the focus on patient safety is intensifying. Ensuring that medical devices are free from defects and are performing as intended is crucial for preventing adverse effects on patients. This focus on safety is driving the growth of the validation and verification market, as manufacturers strive to comply with the highest standards of safety and performance.

Browse Complete Summary and Table of Content @ https://intentmarketresearch.com/latest-reports/medical-device-validation-and-verification-market-3047.html

Market Segmentation: Type of Services and Applications

The medical device validation and verification market is segmented based on the type of service offered and the application of the medical devices. Here’s a breakdown:

1. Types of Services

Validation Services: These services ensure that medical devices are designed and manufactured to perform their intended functions and meet user needs. Validation services include process validation, cleaning validation, and installation qualification, among others.

Verification Services: Verification services ensure that the medical device meets specific design requirements, such as mechanical and electrical specifications. These services include software verification, performance testing, and safety testing.

Testing Services: Testing services are used to assess the quality and reliability of the medical device through testing under various conditions, such as temperature, humidity, and mechanical stress.

2. Applications of Medical Devices

Diagnostic Devices: Diagnostic devices, such as imaging systems, blood glucose meters, and blood pressure monitors, need rigorous validation and verification to ensure accuracy and reliability.

Therapeutic Devices: Devices used for treatment, such as infusion pumps, pacemakers, and surgical instruments, require validation and verification to confirm their efficacy and safety.

Monitoring Devices: Medical devices used to monitor patients, such as heart rate monitors, EEGs, and oxygen sensors, must be validated and verified to ensure continuous and accurate monitoring.

Major Key Players:

BSI Group

Bureau Veritas

Charles River

Dekra Testing and Certification

Element Materials Technology

Eurofins Scientific

Intertek Group

Pace Analytical Services

Quest Global

SGS

Sterling Medical Devices

TUV Rheinland

WuXi AppTe

Regional Insights: Medical Device Validation and Verification Market

The medical device validation and verification market is geographically diverse, with different regions experiencing varying rates of growth:

1. North America

North America is the dominant market for medical device validation and verification services. The United States, in particular, is a key player, driven by high healthcare spending, the presence of major medical device manufacturers, and strict regulatory requirements. The FDA’s oversight and continuous regulatory updates further fuel the demand for validation and verification services.

2. Europe

Europe holds a significant share of the global market, with countries like Germany, the UK, and France leading the way in medical device innovation and manufacturing. The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have raised the bar for regulatory compliance, driving the need for robust validation and verification processes.

3. Asia-Pacific

The Asia-Pacific (APAC) region is expected to grow at the fastest rate during the forecast period. Emerging economies such as China, India, and Japan are witnessing significant developments in their healthcare sectors. As the demand for medical devices increases in these countries, there is a growing need for validation and verification services to meet both local and international standards.

4. Latin America and Middle East & Africa (MEA)

The market in Latin America and the Middle East & Africa is relatively smaller but is expected to grow steadily. Improvements in healthcare infrastructure and increasing regulatory frameworks are driving the demand for medical device validation and verification services in these regions.

Challenges in the Medical Device Validation and Verification Market

Despite its growth, the medical device validation and verification market faces several challenges:

1. High Cost of Validation and Verification

The cost of performing thorough validation and verification can be a significant barrier for small and medium-sized medical device companies. These processes often require substantial investment in testing equipment, personnel, and time.

2. Stringent Regulatory Landscape

While stringent regulations ensure the safety and effectiveness of medical devices, they can also be a challenge for manufacturers trying to navigate complex regulatory environments. Ensuring compliance with ever-evolving regulations across different regions can be time-consuming and costly.

3. Shortage of Skilled Workforce

The validation and verification process requires highly skilled professionals with expertise in regulatory requirements, testing procedures, and quality assurance. There is a growing demand for skilled workers, and companies must invest in training to keep up with market needs.

Future Outlook for the Medical Device Validation and Verification Market

The future of the medical device validation and verification market looks promising. With the increasing demand for advanced medical devices and heightened focus on patient safety, the need for rigorous validation and verification processes will continue to rise. Furthermore, the growing adoption of digital technologies such as AI and machine learning in the healthcare sector will streamline these processes, reducing costs and improving efficiency. 

FAQs

1. What is the difference between validation and verification in medical device development? Validation ensures that a device is designed and manufactured for its intended purpose, while verification ensures that it meets specific design specifications.

2. Why is the medical device validation and verification market growing? The market is growing due to increasing regulatory requirements, the rise in demand for medical devices, advancements in technology, and a greater focus on patient safety.

3. Which region is expected to experience the fastest growth in the medical device validation and verification market? The Asia-Pacific region is expected to witness the highest growth rate in the coming years.

4. What are some key challenges faced by the medical device validation and verification market? Challenges include high costs, stringent regulatory requirements, and a shortage of skilled professionals.

5. How does technology impact the medical device validation and verification market? Technological advancements, such as AI and machine learning, are expected to improve the efficiency of validation and verification processes, reducing costs and increasing accuracy.

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[mariacallous]

Today the Supreme Court of the United States heard oral arguments in a consequential case that threatens to curb access to medication abortion across the country.

A central issue in the case is the safety of the drug mifepristone, the first in a two-pill regimen used to induce an abortion. The drug blocks a hormone needed for pregnancy and has been approved by the US Food and Drug Administration since 2000.

That FDA approval is being challenged by a coalition of antiabortion doctors and activists, the Alliance for Hippocratic Medicine, which is asking for the pill to be removed from the market. The group has alleged that mifepristone is dangerous to patients, citing a 2021 study that found higher rates of emergency room visits following medication abortion. However, that study was retracted in February after an independent review found problems with how the authors analyzed and presented the data.

During Tuesday’s arguments, a major line of questioning from justices was about ER visits following mifepristone use and whether the FDA’s loosening of regulations on the drug in recent years has resulted in an increase in these visits.

“I think ER visits are definitely the wrong measure when looking at safety,” says Michael Belmonte, an ob-gyn and fellow at the American College of Obstetricians and Gynecologists. “It’s important to recognize that the vast majority of people that go to the emergency room are going just for reassurance rather than a true safety concern.”

Belmonte says the more important measure is serious adverse events, which are extremely rare with medication abortion. “Adverse events happen with any medication or procedure and, quite frankly, the adverse events that occur with these medications are extremely rare in comparison to things that we use every day,” he says.

Significant adverse events include hospital admission, blood transfusion, infection, and death. A 2013 peer-reviewed study found that, among 233,805 medication abortions provided in 2009 and 2010, these significant adverse events or outcomes were reported in 1,530 cases, less than 1 percent.

“Many women might go [to the ER] because they’re experiencing heavy bleeding, which mimics a miscarriage, and they might just need to know whether or not they’re having a complication,” said US Solicitor General Elizabeth Prelogar, who is defending the FDA, in oral arguments on Tuesday.

Belmonte says it’s worth noting that the abortion pill regimen is meant to cause bleeding and cramping. While those effects may be troubling to some patients, it’s a function of the medication and a sign that it’s working. “Mifepristone really just prepares the uterus for evacuation, and so, inherently, mifepristone alone doesn’t tend to cause any bleeding, cramping, or other side effects,” he says. Misoprostol, the second drug used in a medication abortion, is what causes bleeding and cramping.

Ushma Upadhyay, a public health social scientist at the UC San Francisco who studies medication abortion, says many patients who visit an emergency department after a medication abortion are alarmed by the bleeding the medication causes, but that doesn’t mean they’re experiencing a serious adverse event. “When people have a medication abortion they’re experiencing it alone, and they don’t have a provider with them to ask questions,” she says. “People are going to the ER to understand whether the bleeding that they’re experiencing is normal and to assess whether the medications worked.”

She says some patients just want an ultrasound to confirm they are no longer pregnant, since pregnancy hormones stay in the body for several weeks after an abortion, and thus an over-the- counter pregnancy test may not be accurate.

One factor that seems to influence ER visits after a medication abortion is greater distance traveled to obtain that abortion, according to research published by Upadhyay in 2017. She says that’s likely because those patients don’t have an abortion clinic nearby or a reproductive health clinic nearby that they can go to with questions.

“It is rare for a patient to experience even a minor complication from a medication abortion, and the risk of death is so small as to be nearly nonexistent,” wrote Jack Resnick, immediate past president of the American Medical Association, in a March 15 statement. “Continuing a pregnancy poses far greater danger; the risk of death during or after childbirth is approximately 14 times higher than the risk of death from abortion-related complications.”

As of December 2022, the FDA reported that approximately 5.9 million women have used mifepristone in the US for medical termination of pregnancy, and 32 women have died after taking it. The agency cautions that “these events cannot with certainty be causally attributed to mifepristone” because not enough information is known about the patients’ health, care they received, or other drugs they were taking at the time.

Ultimately, the Supreme Court case may hinge not on the question of the drug’s safety but on a technicality called “standing”—that is, whether the plaintiffs are the right party to bring this case to the court. Plaintiffs must show that they are the aggrieved or injured party in order to sue.

The Alliance for Hippocratic Medicine argues that physicians could be harmed by treating patients who suffer adverse health effects after taking mifepristone. Much of the justices’ questioning on Tuesday focused heavily on whether this group had proven such harm. If the justices find that the plaintiffs do not have standing, the case would be dismissed. The court is expected to rule by the end of June.