#510k Consultants

[izielhealthcare]

How to Choose Regulatory Consulting Services?

The top medical device consultants have relevant industry experience have relevant experience within the industry, knowledge of the right regulatory frameworks, and proven experience working on similar projects. Regardless of whether you’re trying to develop a regulatory strategy, prepare for submission or respond to the FDA, working with a consultant who’s succeeded in similar situations can increase your chances of a favorable outcome.

IZiel implements an Outcome-Based Delivery Model to provide a complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA & India collaborate to develop a Cost-Effective Model to complete USFDA Approvals for customers in USA, Europe and Asia.

Upon completion of Engineering & QMS Documentation, the regulatory team of IZiel conducts the predicate device search, comparative analysis and ensure all the necessary standards are complied with. Thereafter, IZiel team initiate the writing of 510(k) / PMA, which is verified and approved by our US Regulatory Consultants. Our highly experienced US regulatory consultants include Ex-FDA Auditors, have conducted 3500 + reviews and approvals and have experience with Class I, II & III devices in Cardiology, Neurology, Image Diagnostics and Orthopedic products.

[i3c-global]

FDA 510k Clearance for Medical Device and IVDs

FDA 510k - An Overview

FDA 510k is a file containing sufficient information about a device to demonstrate that the medical device is at least as safe and effective as legally marketed devices that are not subjected to PMA. Organizations planning to launch Class I, II, and III devices in the United States intended for human use must submit a 510(k) if pre-market approval is not required.

Most class 1 devices are exempt from FDA 510k requirements. During the review of the file, if the FDA finds the device to be substantially equivalent, it will grant the FDA 510k clearance for medical devices with a ‘(k)’ number.

We offer technical and scientific assistance in identifying a suitable predicate device, regulation number, and device code, along with file drafting, e-copy conversion, and submission through the US Agent service. Few manufacturers opt for Q submission before final submission.

Role of I3CGlobal Consultants

As a prominent FDA 510k Consultants on a global scale, we have gained the trust of more than 350 plus manufacturers and specification developers. Our team consists of highly skilled subject-matter experts, assuring timely file preparation for 510(k) clearance irrespective of the manufacturer’s size or the regulatory knowledge of their internal team.

With an impressive 85% success rate, a track record of over 350+ clearances worldwide, and a history of serving more than 150+ manufacturers and specification developers since 1999, we proudly stand out from others in terms of quality and service cost.

Our dedication goes beyond mere verbal or email communication; we painstakingly assemble the complete files on behalf of our clients and take full responsibility until the 510k approval is obtained.

F

DA 510k Predicate Device

The term Predicate Device refers to a FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.

Substantial Equivalence Definition

It is a must to demonstrate substantial equivalence to a legally US-marketed device with similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but are not limited to

Intended use,

Design,

Safety,

Adherence to standards,

Labelling,

Biological Compatibility,

Performance characteristics,

Materials used in the construction/ chemical composition,

Manufacturing Methods,

FDA 510k Predicate Device

The term Predicate Device refers to a FDA 510k or PMA-cleared and legally marketed device in the USA with the same (a) intended use, (b) indications for use, and (c) similar technological characteristics as the device in question. It is crucial to note that the predicate device must be a single unit, if possible, and currently available in the USA market without any product recalls in the past years.

Substantial Equivalence Definition

It is a must to demonstrate substantial equivalence to a legally US-marketed device with similar intended use. Proving substantial equivalence to the reference device affirms that the subject device is as safe and effective as the predicate device. The key criteria for determining Substantial Equivalence include establishing similarity are the following, but are not limited to

Intended use,

Design,

Safety,

Adherence to standards,

Labelling,

Biological Compatibility,

Performance characteristics,

Materials used in the construction/ chemical composition,

Manufacturing Methods,

Get more Information : https://www.i3cglobal.com/fda-510k/

[isocyprys]

ISO 13485 Certification in Cyprus: A Comprehensive Guide for Medical Device Manufacturers / Uncategorized / By Factocert Mysore

ISO 13485 Certification in Cyprus

ISO 13485 Certification in Cyprus In the ever-evolving clinical tool employer commercial enterprise business enterprise business organization, ensuring the safety of affected characters and products remains paramount. For organizations operating in Cyprus, wearing out ISO 13485 Certification in Cyprus suggests a dedication to one’s critical factors. This certification demonstrates a sturdy Quality Management System (QMS) that prioritizes regular layout, development, production, set up, and servicing of clinical devices.

What is ISO 13485?

ISO 13485 Certification proves that your clinical device follows proper QMS(Quality Management Systems) from layout and production to set up and servicing.

It fulfils ill QMS requirements in countries like Europe, Canada and Australia.

It also serves as the basis for QMS Compliance in countries like Japan, Korea and Brazil.

The scientific device industry is one of the most touchy with rules and OK requirements.

Suppose a person’s lifestyle is at stake. In that case, the protection and reliability of the tool become non-negotiable, and proper requirements must be in place to ensure the consistency of high-quality transport.

Hence, regulatory necessities ensure that proper practices are followed, from design to market placement, as well as the provision and protection of clinical devices.

Who needs ISO 13485 Certification in Cyprus?

It is meant for medical gadget designers, manufacturers, and after-sales provider stakeholders. [If your company manufactures medical devices] Certification bodies can use it in auditing procedures. What are the blessings of ISO 13485 Certification in Cyprus?

Many other ISO Certifications observe the identical trend of being non-obligatory and voluntary in most markets.

Even if you observe the requirements and directives without certification, it will still give you many advantages.

However, getting a certification from a 3rd birthday celebration lets you in regulatory approaches.

Taking up the certification will assist you in setting up a marketplace, getting the right of entry to exclusive international locations (wherein miles are a prerequisite), and enhancing your sales.

Will assist in increasing efficiency, cutting charges & setting up your dedication to satisfaction within the atmosphere.

Increased Consumer Trust and Brand Reputation.

It will assist you in decreasing the chance of expensive product recalls, which can harm you.

In the United States, The Regulatory body, FDA, allows clinical tool manufacturers to post ISO 13485 Certification in Cyprus audit reviews in the vicinity of evidence of compliance with its high-quality structures guidelines(QSR)

The significant tiers of ISO 13485 Certification in Cyprus implementation:

Understanding the standard requirements

Gap analysis of the contemporary device and the necessities

Stagewise is making plans for the QMS established order.

Providing the specified education for the QMS team

Documentation of the QMS, including the information

Internal Quality Audits and CAPA

Management assessment meetings

Medical device corporations should hire experienced ISO experts who know all threat gadgets. The regulatory requirements are continuously being reviewed & amended with emphasis on patient safety.

Hence, for your medical tool employer, it’s essential to lease consultants who integrate and identify unique product regulatory necessities along with MDR, IVDR, or FDA 510k to be on the side of different vital requirements.

Conclusion:  ISO 13485 Certification in Cyprus

Obtaining ISO 13485 certification in Cyprus signifies a significant achievement for your medical device company. It’s a testament to your commitment to upholding rigorous quality standards throughout your entire product lifecycle.

Why Factocert for ISO 13485 Certification in Cyprus

We provide the best ISO consultants Who are knowledgeable and provide the best solution. And to know how to get ISO certification. Kindly reach us at contact@factocert.com. work according to ISO standards and help organizations implement ISO Certification in Cyprus with proper documentation.

For more information, visit ISO 13485 Certification in Cyprus.

RELATED LINKS ISO Certification in Cyprus ISO 9001 Certification in Cyprus ISO 14001 Certification in Cyprus ISO 22000 Certification in Cyprus ISO 27001 Certification in Cyprus ISO 45001 Certification in Cyprus ISO 13485 Certification in Cyprus CE MARK  in Cyprus

[swapnamakro]

Medical Device Regulatory Publishing - FDA 510k Submission | MakroCare

MakroCare provides comprehensive Medical Device Regulatory Submission Consultant & FDA 510k publishing services. Our team makes sure that your product complies.

[adamsbrown01]

Take a premium advantage of MAVEN's Premium Organizational Management Services. These services are only for clients who are completely invested in making their plant highly compliant and are ready to consider regulatory compliance an important parameter for their organizational success and make necessary resources available to achieve the same. Maven provide the best solution to get US FDA 510K Approval for medical equipment.

[jonesmiller001]

Take a premium advantage of MAVEN's Premium Organizational Management Services. These services are only for clients who are completely invested in making their plant highly compliant and are ready to consider regulatory compliance an important parameter for their organizational success and make necessary resources available to achieve the same. Maven provide the best solution to get US FDA 510K Approval for medical equipment.

[allensmith01]

Take a premium advantage of MAVEN's Premium Organizational Management Services. These services are only for clients who are completely invested in making their plant highly compliant and are ready to consider regulatory compliance an important parameter for their organizational success and make necessary resources available to achieve the same. Maven provide the best solution to get US FDA 510K Approval for medical equipment.

[pharmaceuticaldevelopmentgroup]

510(k) Submission & FDA 510k Submission - Whether manufacturing a medical device or using a CMO, medical device consultants can prove valuable to 510k submission and FDA inspection readiness. More info: https://pharmdevgroup.com/medical-device-consultant-review-quality-management-system-help-with-510k-submission/

[izielhealthcare]

USFDA Consulting for Medical Device

As we all know, some USFDA regulations are extremely specific and special for medical devices and IVD which are supposed to be sold in the USA.

So even for Global manufacturers, approval in many countries and selling them would not just automatically give approval for sale in the USA.

Recommending USFDA consulting to medical device and IVD manufacturers may look sales gimmick so let us first look what are the requirement and corresponding regulations or documentation.

510K submission, IDE (investigation device exemption) submission or clinical trials, for Classification query and resolution, if the manufacturer is outside then effective representation, Audits, and audits of suppliers, form 483, and warning letter resolution, apart from other general guidance on day-to-day affairs like pre-submission meeting, 21 CFR part 820 understanding.

IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, the IZiel team works with their regulatory team in the USA to complete the submissions (510k or PMA) for USFDA Approvals.

[ftyfyufyfyfu]

What is Peak Flow Meter Vs Spirometer

The information provided on our website is not intended to replace professional medical or healthcare advice. It is our aim to help make certain health-related information more readily available and useful to you, however, our website cannot and does not guarantee health-related improvements or outcomes.

Any information provided to you by, or linked to from, our website, does not constitute medical advice, diagnosis, or treatment, nor you should rely on that output as medical advice, diagnosis, or treatment. You should always talk to a qualified medical or healthcare professional about any medical conditions.

Any decisions you take affecting your health should always be made in consultation with a qualified medical professional. You should not rely on the information set out on our website as your primary tool for making health-related decisions.

Enquire or Share Your Questions If Any Before the Purchasing This Device -  https://www.safeymedicaldevices.com/enquire-now/

If you suffer with asthma, you will be well versed in the different tests which can be carried out to assess your lung function and overall health.

A spirometer and peak flow meter can both be utilised to test just how well your lungs are functioning. But it’s important to note that whilst both are useful tools in the diagnosis and management of asthma, they are used in different ways, both offering different purposes.

Read this helpful guide to find out the definitions of each and the key difference between them, to help you take control of your condition.

What Does a Spirometer Do?

So, first things first, what exactly can a Spirometer achieve and what is it used for in the world of lung function?

As a simple, quick, and painless way to check your lungs and airways, the NHS state that a spirometer can be used to diagnose a lung condition, if you feel you are experiencing symptoms OR if your GP feels you may be at risk of developing a certain lung condition.

Despite its effectiveness when it comes to diagnose lung conditions such as asthma and COPD, a 2015 US study showed that just 47.6% of 134,208 asthma patients had spirometry performed within a year of their diagnosis.

How Does a Spirometer Work?

As a test for lung function, the Spirometer will take place at a scheduled appointment, usually at your GP with a practice nurse.

Before starting, you will be shown by the nurse how to blow into the spirometer.

You may also have to wear a clip on your nose – this is to make sure all the air goes into the mouthpiece and doesn’t escape anywhere.

When you are ready to be tested, you’ll sit comfortably and:

✅ Take a deep full breath in, so that your lungs are filled with air

✅ Close your lips tightly around the mouthpiece

✅ Exhale as quickly and forcefully as you can, making sure you empty your lungs fully

The spirometry test will usually need to be repeated at least 3 times.

This is to make sure a reliable result is achieved.

The nurse or other health care professional may then ask you to use your inhaler (salbutamol), wait for 15 minutes, and then repeat the test.

For some other medication, such as ipratropium bromide the wait may be 30-45 minutes between tests. This is called a reversibility test and is used to see if the medication makes an improvement to your breathing.

What does a Peak Flow Meter do?

On the other hand, a peak flow meter, is a hand-held device used to measure the rate of a person’s air flow (the rate at which air is blown out of the lungs).

Patients can use peak-flow meters as a helpful way to regularly measure their airflow and work out their maximum speed of expiration.

This is known as the peak expiratory flow (PEF).

Peak flow is a useful tool when it comes to diagnosing asthma.

If you find that you are experiencing symptoms relating to asthma, your doctor will use a peak flow meter to measure your air flow and to see how just open your airways are.

How Does a Peak Flow Meter Work?

It’s important to be able to use your peak flow meter correctly otherwise the readings will not be accurate.

In the first instance, your doctor or nurse will show you exactly how to take a peak flow reading and follow the steps below:

✅ Initially, you will need to put the marker to zero.

✅ Inhale deeply

✅ Then seal your lips tightly around the mouthpiece and blow as hard and as fast as you can into the device

✅ Take a note of what your reading is

✅ Do this again for another two blows, one straight after the other and note the readings. Remember to slide the red indicator back to its start position each time.

✅Record the highest reading, with the date and time.

When else might a Peak Flow Meter be helpful?

As a way in which to monitor your asthma, a Peak Flow Meter could also be used in the following instances:

➡ When your medication has changed (i.e., a new drug or different dose)

➡ Are relying on your blue reliever inhaler more than usual

➡ If you know that you have been exposed to one of your known triggers (for example, pollen)

➡ If you are feeling generally unwell

➡ If your asthma symptoms are keeping you up at night

Test Results

The first time a patient uses a peak flow meter to measure their lung function, a baseline or personal best is made clear.

From then on, the results of each test will be compared with this initial baseline and placed into one of three peak flow zones.

A spirometer produces two measurements: forced vital capacity – known as FVC, and forced expiratory volume-one second, called FEV1.

FVC is the maximum volume of air that can be exhaled from full inhalation, in which the patient exhales as forcefully as possible. The FEV1 measures how much air a person can exhale in one second, following on from a forced breath.

When it comes to the spirometry, the value of FEV-1 is divided by the FVC, producing a third number on the test results – the FEV1/FVC ratio. This number highlights the percentage of the lung size – FVC – that can be exhaled in one second. The percentage is then compared with normal values. Furthermore, a flow-volume graph is produced from the test to see how well the lungs are performing.

Size

Whilst a peak flow meter is a small, portable, cylindrical device that fits snugly in the palm of your hand, a spirometer is a larger device that is usually square or rectangular in its shape.

There are various models of spirometer: from a Pneumotachometer, which measures the flow rate by detecting pressure differences across fine mesh, to a Fully Electronic Spirometer, which produces airflow rates without the need for fine meshes.

Depending on the model, there will be differences in the features, such as bulkier mouthpieces or touchscreen elements.

Cost

There are vast cost differences between a peak flow meter and spirometer. As the peak flow is a simpler piece of equipment, the costs tend to be quite low. Whereas spirometers can be much more expensive, coming in at around £2000 for one of good quality.

For more information -  https://blog.safeymedicaldevices.com/peak-flow-meter-vs-spirometer

[operonstrategist]

This blog nicely explains how to get FDA approval for medical devices step by step. Read till the end.

[meeraoperon]

What is 510k and its clearance process?

What is 510k and its clearance process?

510k approval is a process to get marketing clearance for a Class II Medical Device. Class II Medical Devices are non-invasive devices usually meant for secondary treatment and aid. 510k is also referred to as Pre-Market Notification.

The process of getting a 510k clearance requires finding an equivalent product (predicate device) to a new product to prove its substantial equivalence. Once the device is proven equivalent to an already approved equivalent it can be legally marketed as per US FDA guidelines.

510k submission checklist

The entire process of the 510k is divided into two phases:

(I) Acceptance Review

Acceptance review takes up to 15 days. In case, the 510k is not accepted at the primary level, RTA is issued. RTA refers to Refuse to Accept. In such a case some more documentation is needed to validate the product.

(III)Substantive Review

The substantive review takes up to 60 days. At this stage, the approval body may ask for additional information to justify the indicated use of the product.

What does FDA require as additional information?

The additional information, in general, has those facts that completely justify the intended use or impact of the product.

Additional information requests include:

a. Improper device description

b. Discrepancies in the indications for use or device description

c. Data related to indicated use

d. Inability to comply with set standards or regulations

e. Non-satisfactory clinical data

Operon Strategist is medical device consultancy. which provide the consultation on FDA 510k clearance process

[jennyholmes]

Easiest Steps to Get FDA Approval for Medical Devices

Know the proper classification

It is very important to classify your product to identify which regulations are applicable for your device and work on the manufacturing process accordingly. Medical devices can be categorized into 3 classes, class I, which has the lowest risk; class II, and class III, which includes the ones with the highest amount of risk. The classification should be carried out with proper guidance by FDA 510k consultants before the development process begins. This will help you in managing the requirements and the testing. A pre-market review is essential for Class II and Class III categories. 

Develop a prototype

Prepare a prototype with the assistance of FDA 510k consultants, for testing in laboratory environments before it is ready for human use. This will tremendously reduce the potential risk posed by the device and thus save humans from any kind of injuries. After this, your device is ready for clinical trials 

Submit the application

For getting an FDA 510k medical device approval, submitting a pre-market application is necessary. For doing this you will be needing an FDA verification and validation for your device. Let us see what are the various aspects of FDA verification and validation are.

For FDA verification you will have to make sure that you are correctly designing the device. For the correct device design, you should ensure that requirements are implemented, verified and if the standard requirements are met. For FDA validation, you should be confident that you are designing the right device. Seeking validation will make you ensure that your device is meeting the needs of the device users, the stakeholders of your company, and the needs of the regulatory stakeholders. An FDA consultant for medical device can help you most appropriately.

Wait for review and approval

Once you have applied, wait for the FDA 510k premarket approval of your device. 

Maintain the FDA compliance

If you have got the FDA 510k medical device approval, it does not mean that you are free from any kind of restrictions. Maintaining the compliance of medical devices is very important. Ensure that this compliance stays throughout the life span of the device. 

Summary: Getting approval from the FDA is not an easy job. It requires a lot of information and patience. Learn some of the easy ways in which you can obtain FDA approval for your medical device.

The Food and Drug Administration concerns a lot of industries like food, beverages, drugs, cosmetics, and even medical devices, and each of these industries has different regulations to be met. Complying with your medical devices with the FDA regulations is a very time-consuming and tedious process. there are so many aspects to be kept in mind for getting FDA approval. You will be needing the help of an FDA consultant for medical device.

You should know that FDA compliance and FDA approval are two different things. FDA compliance is fulfilling the safety regulations by the FDA, while FDA approval means getting approval by the FDA after meeting all the requirements. Following are some of the easiest steps for obtaining a 510K premarket approval by the FDA.