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Rudy Boxman

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[omcmedicalblogs]

Smart Wearables Regulations in the EU | OMC Medical Limited

The booming technological aspects have constantly challenged regulations established worldwide in the modern century because the regulations either inadequately govern novel technologies, or there always exists a scenario where the devices cannot be categorized within a given regulation.

Smart wearables are one of those aspects falling into such debate in recent times. Days are no longer from the fact that these smart wearables may draw strict regulations to be in place.

How are these general wellness devices regulated? What are these devices classified as?

Unlike medical devices, these devices are intended to be used for wellness reasons such as to improve the lifestyle by monitoring the user’s diet and exercise, enhancing physical activity etc., and they are ideally not intended to get involved in any diagnosis or therapy.

Intended Use

Any device is subject to a regulation based on its “intended use” declared by the manufacturer. Hence the manufacturer needs to pay utmost attention in declaring what their device supposed is to be used for real-life scenarios.

Smart wearables are often confused with medical devices, or sometimes they are by mistake considered medical devices if a vague intended use statement is written for the device.

Generally, smart wearables are low-powered electronic equipment intended to be worn by the user, such as wrist-worn, neckband, body-worn, adhesive to the skin surface to collect some data and transfer the information to a mobile device application.

Sensors and electronic components present in your smart wearables monitor your activities which could be determining the body’s orientation, climbing stairs, speed of walking or running, heartbeat, oxygen levels, respiratory rate, sleep patterns, etc.

Now the question here is, should one consider this a medical device when the device monitors HR, SpO2, and respiratory rates, which a physician usually monitors to determine the state of health and use these data to diagnose any physiological condition.

The answer is not straightforward, but there are smart wearables in the market that obtain FDA clearance that claims to perform certain medical purposes as the intended purpose. Such devices fall under the medical device category.

Hence, if the manufacturer claims that the device has a “medical purpose” in its intended use, the device falls under a medical device. Claims are critical in these cases.

How is my smart wearables regulated?

In Europe, there is no separate regulation released to date for smart wearables; however, depending on the nature of your device, it is mandatory to adhere to the applicable EU directive or EU Regulation. CE marking is mandatory for all categories of equipment entering the EU market.

It is essential to identify the applicable regulations for the device based on the nature and functionality of the equipment. For any electronic radio equipment, the following EU directives apply:

· Radio Equipment Directive 2014/53/EU

· EMC Directive 2014/30/EU

· Low Voltage Directive 2014/35/EU

· RoHS and REACH Directive 2011/65/EU

· WEEE Directive 2002/92/EC

Originally Published at: https://omcmedical.com/smart-wearables-regulations-in-the-eu/

[isocertificationinkenya]

CE MARK Certification in Nepal

        A leading provider of CE certification in Mexico, Guadalajara, Tijuana, Monterrey, Merida, Leon, and all other important Mexican cities is Certvalue. Are you seeking for product certification in Mexico, or do you wish to import/export your product or get it certified under the CE Mark? we will then assist you with this. With the aid of CE Mark Consultants in Mexico, CE Mark Certification is a simple process that facilitates the import or export of products from one nation to another. An indication that a product satisfies applicable European directive standards is provided by its certification. Product ranges that are exported or marketed in European countries must comply with this requirement.The manufacturer certifies that their product complies with the appropriate European Directive(s) by using the initials CE Mark.The procedures listed below are followed by management while giving CE certification consulting in Mexico. These procedures have produced 100% of the success we have had thus far in advising different manufacturing units in India to obtain a CE Mark for their goods in Mexico.

CE Mark Requirements in Mexico:

Product Controls: Before products may be sold, they must be marked with the CE Mark Certification in Leon in accordance with specific EC directives that need the CE Mark.

Relevant EU regulations: It is the Product Manufacturers' exclusive obligation to determine which EU regulations apply to their products.

method for Conformity Assessment: Only once a product has been certified in Mexico and conforms with all relevant directives can it be sold. This also requires that the conformity assessment method be followed correctly. 

EC Declaration: The product has the CE Mark  in Mexico once the maker prepares an EC declaration of conformance.

Third Party evaluation: Should the directive specify it, the conformance evaluation process must involve an authorised third party.

Use of Logo: The CE Mark Certification in Guadalajara must be at least 5 mm in size, and if it is larger, its proportions must be maintained. This is a requirement for every product that bears the CE Marking. It can only add more CE Marks if they have distinct meanings. Avoid overlapping the CE Mark in Mexico to avoid confusion and to preserve the CE Mark's readability and visibility. 

    Our specialists will conduct a micro-level survey of your organisation and analyse any gaps. Determine which directive(s) apply. determining unified standards. Testing your product to make sure it complies with the specifications. Write a report about the exam. Create a file for technical construction. Create a technical file documentation that complies with the relevant specifications. Create and sign the self-declaration of conformance from the manufacturer. Submit an application for the product's CE Mark Certification in Monterrey. Statement of compliance.

Advantages of CE Marking Certification in Mexico:

Market Access to the EU: EEA members are allowed to trade goods with the CE mark. This gives Mexican producers that want to sell their goods in Europe a lot more export options.

Enhanced Credibility: The CE Mark is acknowledged on a global scale as a symbol of excellence and adherence to strict EU regulations. This improves the standing of Mexican businesses and their goods, increasing their appeal to clients and partners abroad.

Customer Confidence: CE Marking provides reassurance to customers that a product satisfies strict standards for environmental, health, and safety. In both domestic and foreign markets, this may boost customer happiness and trust. 

Competitive Advantage: Businesses who have obtained CE Marking accreditation have the potential to outperform those that have not, especially in the event that they are bidding on foreign contracts or tenders that need it.

Simplified Regulatory Compliance: The EU legal compliance of a product is attested to by the CE Mark. By doing this, it may be possible to streamline regulatory procedures and lessen the requirement for further testing and certification when entering markets that accept the EU or have agreements with it.

Encourages Innovation: Upholding the standards necessary for CE marking may stimulate innovation and enhance the safety and quality of products, creating an environment in the workplace where continual development is valued.

Risk management: By helping businesses identify and reduce any dangers connected to their products, compliance with CE Marking rules can lower the possibility of expensive recalls or legal problems.

Improved Supply Chain Relationships: Companies having CE Marking certification may be preferred by suppliers and partners as it guarantees constant product quality and adherence to international standards.

How to get CE Mark Consultant in Mexico?

    You may contact us at contact@certvalue.com  or visit our official website at our top CE Mark Services in Mexico if you're seeking information on how to obtain CE Mark Certification in Mexico. Give us your contact information so that one of our certification specialists may get in touch with you as soon as possible to better understand your needs and offer the finest service available on the market.

[iso9001certificationnepal]

CE MARK Certification in Nepal

        A leading provider of CE certification in Mexico, Guadalajara, Tijuana, Monterrey, Merida, Leon, and all other important Mexican cities is Certvalue. Are you seeking for product certification in Mexico, or do you wish to import/export your product or get it certified under the CE Mark? we will then assist you with this. With the aid of CE Mark Consultants in Mexico, CE Mark Certification is a simple process that facilitates the import or export of products from one nation to another. An indication that a product satisfies applicable European directive standards is provided by its certification. Product ranges that are exported or marketed in European countries must comply with this requirement.The manufacturer certifies that their product complies with the appropriate European Directive(s) by using the initials CE Mark.The procedures listed below are followed by management while giving CE certification consulting in Mexico. These procedures have produced 100% of the success we have had thus far in advising different manufacturing units in India to obtain a CE Mark for their goods in Mexico.

CE Mark Requirements in Mexico:

Product Controls: Before products may be sold, they must be marked with the CE Mark Certification in Leon in accordance with specific EC directives that need the CE Mark.

Relevant EU regulations: It is the Product Manufacturers' exclusive obligation to determine which EU regulations apply to their products.

method for Conformity Assessment: Only once a product has been certified in Mexico and conforms with all relevant directives can it be sold. This also requires that the conformity assessment method be followed correctly. 

EC Declaration: The product has the CE Mark  in Mexico once the maker prepares an EC declaration of conformance.

Third Party evaluation: Should the directive specify it, the conformance evaluation process must involve an authorised third party.

Use of Logo: The CE Mark Certification in Guadalajara must be at least 5 mm in size, and if it is larger, its proportions must be maintained. This is a requirement for every product that bears the CE Marking. It can only add more CE Marks if they have distinct meanings. Avoid overlapping the CE Mark in Mexico to avoid confusion and to preserve the CE Mark's readability and visibility. 

    Our specialists will conduct a micro-level survey of your organisation and analyse any gaps. Determine which directive(s) apply. determining unified standards. Testing your product to make sure it complies with the specifications. Write a report about the exam. Create a file for technical construction. Create a technical file documentation that complies with the relevant specifications. Create and sign the self-declaration of conformance from the manufacturer. Submit an application for the product's CE Mark Certification in Monterrey. Statement of compliance.

Advantages of CE Marking Certification in Mexico:

Market Access to the EU: EEA members are allowed to trade goods with the CE mark. This gives Mexican producers that want to sell their goods in Europe a lot more export options.

Enhanced Credibility: The CE Mark is acknowledged on a global scale as a symbol of excellence and adherence to strict EU regulations. This improves the standing of Mexican businesses and their goods, increasing their appeal to clients and partners abroad.

Customer Confidence: CE Marking provides reassurance to customers that a product satisfies strict standards for environmental, health, and safety. In both domestic and foreign markets, this may boost customer happiness and trust. 

Competitive Advantage: Businesses who have obtained CE Marking accreditation have the potential to outperform those that have not, especially in the event that they are bidding on foreign contracts or tenders that need it.

Simplified Regulatory Compliance: The EU legal compliance of a product is attested to by the CE Mark. By doing this, it may be possible to streamline regulatory procedures and lessen the requirement for further testing and certification when entering markets that accept the EU or have agreements with it.

Encourages Innovation: Upholding the standards necessary for CE marking may stimulate innovation and enhance the safety and quality of products, creating an environment in the workplace where continual development is valued.

Risk management: By helping businesses identify and reduce any dangers connected to their products, compliance with CE Marking rules can lower the possibility of expensive recalls or legal problems.

Improved Supply Chain Relationships: Companies having CE Marking certification may be preferred by suppliers and partners as it guarantees constant product quality and adherence to international standards.

How to get CE Mark Consultant in Mexico?

    You may contact us at contact@certvalue.com  or visit our official website at our top CE Mark Services in Mexico if you're seeking information on how to obtain CE Mark Certification in Mexico. Give us your contact information so that one of our certification specialists may get in touch with you as soon as possible to better understand your needs and offer the finest service available on the market.

[isocertificationrequirements]

What is CE marking? Why CE Marking Certification Is Necessary?

What is CE marking?

CE Marking is a certification that determines product conformity with health, safety and environmental protection standards.  CE marking applies to product sold within the European economic area (EEA). The CE marking can also be found on products that are sold outside the European economic area but are manufactured or designed in the EEA. CE Marking Certification is also known as CE mark. CE marking certification is mandatory to export products to Europe. The CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable EC directives. The Word "CE" stand for "Conformite Europeene" ("European Conformity"). According to the level of risk of the product, the CE Mark is affixed to a product by the manufacturer or authorized representative after ensuring that the product meets all the CE mark requirements.

Why CE Marking Certification Is Necessary?

CE marking certification for a product is necessary in a number of ways, some of which are listed below.

CE marking Certification on a product gives guarantees that the product is in compliance with the necessary requirements of the European health safety and environmental protection legislations.  It gives more credit and confidence to the manufacturers to push their products to the global market.

CE marking certification on a product also gives assurance to government officials that the product is fit enough to be placed on the market in their country, and thus enhancing global distribution of products

CE marking certification on a product also aids easy and free movement or distribution of a product within the European Union market; it also permits the withdrawal of the products that does not conform with the EEA customs and enforcement authorities or regulations.

CE Marking Process

To apply the CE marking product certification, you need to set up a technical dossier showing that your product fulfills all the EU-wide prerequisites. Being the product's manufacturer, you bear exclusive obligations for ensuring conformity with all requirements. Some of the processes for CE marking are:

Take enquiry about the EU requirements (applicable directive / rule) for your CE Marking

Product.

Check whether your CE product meets the specific requirements for CE Marking Certification.

Check whether your CE product needs to be tested by a Notified Body

Test your CE Marking product personally & subsequently from external agency (If required for your product).

Arrange the technical file / technical dossier / technical construction file.

Affix the CE marking and draft a declaration of conformity (EU Declaration of conformity / EC Declaration of conformity.

Countries Where CE Marking is Mandatory

CE Marking is mandatory in following European countries:

Estonia, Finland, France, Germany, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom, Turkey, Netherlands, Poland, Portugal.

Apart from above specified countries many Asian, African & Middle East countries accept CE Marking as a parameter of product safety.

HOW DO YOU BENEFIT FROM CE MARKING CERTIFICATION?

The CE marking Certification is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EEA).

The benefit for CE manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

Similarly, In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.

IAS Expertise in CE Marking Services

    IAS certification is an accredited certification registrar providing different types of certificate which include the CE marking certificates for various organizations or companies.  Our Organization (IAS) expertise in the industry is second to none as we boast of best hands that have gotten relevant experience in CE marking services. Should you need to get CE marking in India, don't hesitate to reach out to us at IAS certification limited. EAS mainly focusing to conduct audit and ensure everything is properly placed towards getting your CE mark certification.

IAS offer a comprehensive CE marking services and our process is simple and easy. Similarly with, good customer relationship and awesome attention to details, we believe you will have a nice and wonderful experience working with us. In our Organization, technical experts are highly qualified to guide you in every step of CE Marking process. We have given CE Marking services to every size of organization in India & abroad. We at IAS make CE Marking Process very simple for you through our proper guidance. Right from identification of applicable EU directives, selection of CE certification module, arranging CE Mark testing services, preparation of CE Marking Technical file, till making of 'EU Declaration of Conformity' & grant of CE Certificate, Our Company IAS help you on every step.

We offer is simple, good old fashioned honesty, complete integrity, ultimate professionalism and exceptional customer service. It is our belief that just being good at what we do is not good enough. Our services have to be better than our competitors and from what we hear from our clients, it is. We believe that by working closely with our clients, we can provide the consistent, dedicated and honest service you deserve, is a world leading CE Marking company. We have more than 20 years’ experience in CE marking services in India & worldwide. With a wide network of offices IAS is able to provide you CE Certification services in all parts of India & abroad also.

CE Marking Certification Provider:

Don’t wait for clients to come and knock on your door for 

Be proactive – don’t trust in luck. Work and develop your qualifications, choose your target clients and make yourself known. To track your progress and evaluate the effectiveness of your actions, consider making a business plan with targets for number of clients and revenue. Choose a right CE Marking Certification in Bangladesh.

[isocertificationinindia28]

Are there any specific documentation requirements for obtaining CE Mark certification?

/ Uncategorized / By Factocert Mysore

Introduction: CE Mark Certification in India

CE Mark Certification in India In today’s global marketplace, obtaining CE Mark certification in India  is often crucial for manufacturers looking to export their products to Europe. This certification signifies compliance with European Union (EU) regulations, ensuring product safety and quality.

However, understanding the specific documentation requirements is essential for businesses in India seeking CE Mark certification in India. In this blog post, we’ll delve into the intricacies of CE Mark certification in India documentation for Indian companies, guiding you through the process step by step.

CE Mark Certification in India:

Before delving into documentation requirements, it’s crucial to grasp the fundamentals of CE Mark certification in India. 

The CE Mark certification in India indicates that a product complies with EU safety, health, and environmental protection standards, allowing it to be sold within the European Economic Area (EEA). While CE Mark certification in India is not mandatory for products sold in India, it becomes indispensable for those intended for export to the EU market.

Documentation Requirements:

Technical Documentation:

The cornerstone of CE Mark certification in India is comprehensive technical documentation. This includes detailed information about the product’s design, construction, performance, and compliance with relevant EU directives. Technical documentation typically consists of:

Product specifications and drawings

Risk assessment and mitigation measures

Test reports and results

Declarations of conformity

Instructions for use and maintenance

Any relevant design calculations or simulations

Declaration of Conformity (DoC):

The Declaration of Conformity is a formal document in which the manufacturer or authorized representative asserts that the product meets all applicable CE Mark requirements. This declaration must accompany the product and be made available to competent authorities upon request. It should include. CE Mark Certification in Singapore

Manufacturer’s details

Product identification

List of relevant directives and standards

Compliance Statement

Signature and date

Compliance with Applicable Directives:

Depending on the nature of the product, manufacturers must ensure compliance with specific EU directives relevant to their industry. Common directives include:

Machinery Directive (2006/42/EC)

Low Voltage Directive (2014/35/EU)

Electromagnetic Compatibility Directive (2014/30/EU)

Medical Devices Directive (93/42/EEC)

Personal Protective Equipment Directive (2016/425)

Manufacturer’s Risk Assessment:

A thorough risk assessment is vital for demonstrating product safety and compliance with relevant directives. This assessment should identify potential hazards associated with product use and outline measures to mitigate these risks effectively. Documentation of the risk assessment process is essential for CE Mark certification in India 

Notified Body Certificates (if applicable):

In certain cases, the involvement of a notified body may be required for CE Mark certification in India. Notified bodies are independent organizations designated by EU member states to assess product compliance with specific directives. Documentation of the notified body’s assessment and certification must be provided if third-party accreditation is necessary. CE Mark certification in Saudi Arabia

Translation of documentation:

Since CE Mark certification in India  involves compliance with EU regulations, all documentation must be available in an official EU language. Translation of technical documentation, declarations, and labels into English, French, German, or another relevant language may be necessary.

Conclusion:

Navigating the documentation requirements for CE Mark certification in India can be complex, but thorough understanding and meticulous preparation are key to success. 

By ensuring compliance with applicable directives, compiling comprehensive technical documentation, and fulfilling all regulatory obligations, Indian manufacturers can confidently streamline the certification process and access the lucrative EU market. 

With the right approach and attention to detail, CE Mark certification in India can open doors to new opportunities and enhance the competitiveness of Indian products on the global stage.

Why Factocert for CE Mark Certification in India

We provide the best CE Mark 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 CE Mark certification in India with proper documentation.

For more information, visit CE Mark Certification in India

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RELATED ARTICLE

ISO CONSULTANT IN INDIA

[cert3global]

Why Do You Need An EC Representative?

Are you an overseas manufacturer and wish to promote your medical devices and IVDs in Europe? Did you know that in that case, you will have to appoint an EAR (European Authorized Representative before beginning your venture there?

It is worth noting that the EU AR will act as the regulatory representative of your company in the European Market and will then be a point of contact between you or the manufacturing company and the European nation’s Competent Authorities.

The MDR/IVDR has augmented the account abilities of the EU AR. One important alteration involves the AR explicitly sharing the liability with the manufacturing company of the products on the market. Due to the importance of the AR’s role, it is vital to select a European Authorized Representative who will remain committed to acting as your partner in the entire market.

The EU AR is also referred to as an EC Representative or an Authorised Representative.

If you are wondering about the responsibilities of the Authorized Representative, you need to note that apart from acting as a link with the European Competent Authorities, the European Representative is responsible for the following purposes.

Before Marketing

Verifying that the details of technical documentation of the manufacturer are drawn up according to the equivalent conformity process and preserving a copy of the technical specs file as well as a CE certificate for every device the company is likely to launch.

Verifying the EU declaration of the manufacturer’s conformity is aligned with the appropriate conformity evaluation procedure.

Checking that the producer complies with the UDI registration in accordance with Article 27 explained in the MDR, if applicable.

Providing authorization to embrace EU AR’s name as well as the address on the labeling of the manufacturer and other applicable documentation.

Executing an agreement with the manufacturing company to detail the obligations of either manufacturer as well as AR through the lifetime of the product in the EU market.

During Product Lifetime

Reviewing as well as verifying your EUDAMED’S Registration Number application. The Relevant Authority will undergo the final review and equally issue you the SRN.

The representative will have to maintain a copy of every product that you launch technical documentation apart from CE certification. For non-implantable machinery, the EU AR should preserve technical details documentation for at least 10 years starting from the date of launching the product on the market arena. For implantable machinery, the AR needs to maintain the documentation for at least 15 years.

Informing the producer if any type of complaint is raised from the healthcare providers or patients and will be liable to support the FSCA or Field Safety Corrective Action (FSCA) reporting, in coordination with you as well as your importers as well as distributors.

Finally, you need to know that you will require a FSC that stands for Free Trade Certificate which is used as an international export documentation for exporting medical devices as well as IVD medical products. It shows that the products you deal in can be marketed in European countries freely.

View Source: https://medium.com/@freesalescertificate/why-do-you-need-an-ec-representative-1d95fabe7118

[focolvapes]

Is vape oil safe?

Tobacco oil needs to be tested for 17 major categories of tobacco oil quality and safety items and 54 specific indicators before it can be used in production.

1) Nicotine testing according to California 65 requirements.

2) Determination of 4 specific nitrosamine compounds according to FDA technical documents.

3) Test for harmful substances such as propylene glycol and diethylene glycol in electronic cigarette oil.

4）Referring to the United States Pharmacopeia USP heavy metals in nicotine method of determination of heavy metals in vape oil.

5）Referring to USP requirements for testing the microbial content and antiseptic efficacy of vapes

6）TRA toxicity analysis - EU and USA

(7) MSDS safety data sheet service for vapes - according to EU 2001/58/EC, 1999/45/EC, 67/548/EEC, Regulation (EC) No. 1907/2006; US 29 CFR 1910.1200(g), ISO 11014-1 and other international standards Issue safety data sheets.

8) Export EU RoHS Directive

U.S. states: FDA testing FDA registration FCC certification BQB certification UL certification CPSC certification ASTM certification California 65 certification ETL certification CEC certification Energy Star certification

Europe: CE certification ROHS testing REACH testing EUP energy efficiency testing TUV certification GS certification SGS certification

Asia: SASO certification PSE certification TELEC certification KC certification BSMI certification NCC certification BIS certification Middle East COC certification

Australia: GEMS energy efficiency certification CTICK certification SAA certification RCM certification

Africa: COC certification for various African countries

China: CCC certification, CQC certification, mall quality inspection report, security products Ministry of Public Security commissioned report, water-related products water-related approval, ISO9001 certification, ISO14001 certification, TS16949 certification, lithium battery aviation safety certification, air purifier testing

Focol provides 24-hour service, if you have any questions, please visit www.focolvapes.com for consultation

[izielhealthcare]

Steps for Getting CE Marking

All products meeting the definition of medical devices as defined by the EU regulations require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and meets EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.  

The product must comply with all the relevant MDD to MDR requirements of before affixing the CE marking to it.  Although the compliance requirements are similar in many ways, the European route is thought to be less governmental, resulting in shorter times to market, greater acceptance rates of new devices, and lesser costs associated with obtaining conformity certification.

While the benefits of obtaining a CE marking are significant, regulations are always subject to change. New modifications to the European medical device requirements are making the process more similar to that of the FDA when it comes to establishing conformity.

By May 2021, a new Medical Device Regulation (MDR 2017/745) will go into effect throughout the European Union. Despite the changes, there still remains a clear path to establishing conformity and obtaining a CE marking that will allow your company to access European markets.

 Steps

1.       IDENTIFY THE APPLICABLE REQUIREMENTS OF THE REGULATIONS

1.       CLASSIFY THE DEVICE AS PER THE RULES DEFINED FOR CLASSIFICATION OF MEDICAL DEVICES

2.       IDENTIFY AN APPROPRIATE ROUTE TO CONFORMITY

3.       ASSESSMENT OF THE PRODUCT’S CONFORMITY TO EU REQUIREMENTS

4.       COMPILE THE TECHNICAL DOCUMENTATION, QMS & CLINICAL EVALUATION REPORT.

5.       ASSESSMENT BY NOTIFIED BODY

6.       MAKE A DECLARATION OF CONFORMITY AND AFFIX THE CE MARK

IZiel Healthcare has collaborated with Belgium based Obelis (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. Typically, all MDD-MDR transition projects initiate with Gap Assessment. Gap Assessment is a crucial activity during MDR transition.

 IZiel-Obelis collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking by developing Technical File & QMS Documentation, conducting Software Validation, writing CERs and providing EC Rep, EUDAMED, PRRC Services. Our experts are well equipped to conduct this activity with an analytical mindset, resolve any engineering requirements and develop robust regulatory strategy for medical device manufacturers. 

[rudyboxman57]

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[omcmedicalblogs]

LEGACY MEDICAL DEVICES REQUIREMENTS IN EUROPE

Legacy medical devices include all previously regulated devices under the Medical Devices Directives (MDD 93/42/EEC 90/385/EEC) and In-vitro Diagnostic Devices Directive (IVDD 98/79/EC).

Medical Device Coordination Group (MDCG) published the guidance documents on the Application of EU MDR to legacy devices and Legacy device management for Legacy devices.

There are three terminologies to guide the manufacturers – old devices, legacy devices and MDR devices.

‘Old devices’ were placed on the market before 26 May 2021, holding valid Medical Device Directive Certificates or the AIMDD certificates.

‘Legacy Devices’ are those devices that have a valid CE certificate under the directives MDD and IVDD that were placed after 26 May 2021 or those that require a conformity assessment to be carried out.

A Class III device, for example, can be considered a legacy device because of the conformity tests done and valid CE certificates. Class Is / Im devices with self-declared certificates do not fall under this category.

Legacy devices must be MDR compliant under the prescribed transitional timelines set by the MDR (2017/745). The transitional provisions and timelines can be found in Article 120 of the EU MDR.

https://jpcdn.it/img/f11f7ed767582b76241c3f66062badfa.png

This topic focuses on the Legacy Devices requirements per MDR 2017/745. EU MDR aims to implement the following aspects of medical devices:

Identification- This is achieved by Unique Device Identifiers (UDI).

Transparency- The Database available in EUDAMED (European Databank on Medical Devices.) ensures that the device description and details of different economic operators are open and easily accessible for users.

Surveillance-Post-Market Surveillance, vigilance reporting and Periodic Safety Update Reports (PSUR) are prime importance under MDR.

Identification of Legacy Medical Devices

To ensure proper identification of medical devices, UDI is implemented under MDR. Read more about UDI in our article on UDI (Unique Device Identification) system. For legacy devices, the identification is made possible with the help of EUDAMED-DI.

Some manufacturers may have implemented UDI to their medical devices. In such cases, the device identifier is obtained from the UDI-DI. Devices that do not have UDI should have a EUDAMED-DI designated by the manufacturer.

The European Commission document on the Management of legacy devices can be used to understand the different device identifiers.

Application of Post Market Requirements to Legacy Devices

All relevant requirements mentioned in MDR apply to legacy devices as well. This includes post-market surveillance, market surveillance and vigilance.

Manufacturers need to keep in mind the information required under Article 83 and Chapter VII of EU MDR while implementing a post-market surveillance system.

The Notified bodies must consider the new requirements applicable to manufacturers resulting from the transitional provisions as part of the surveillance framework.

Application of other MDR requirements to legacy devices

Application of all other requirements should be implemented to contribute to post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices. This ensures an all-rounded and well-functioning surveillance system.

The other MDR requirements applicable to legacy devices are as follows.

Article 10(12-15)

Obligations of manufacturers for market surveillance, field safety notices and vigilance.

Article 11 (3) (c-g) and 11 (7)

Obligations of Authorised representatives.

Article 13 (2,4,5,6,10)

Importer obligations for IFU, labelling, and register of complaints.

Article 14 (2,4,6)

Distributor obligations.

Article 22

Article on system and procedure packs.

Article 29

Article of registration of medical devices and UDI.

Article 31

Article of registration of manufacturers, authorized representatives, and importers.

Article 83-100

Articles 83-88 on PMS, PSUR, vigilance, serious incident reporting, field safety corrections, and trend reporting.

Articles 89-99 on analysis of data, implementing acts, market surveillance activities, electronic system on market surveillance and others.

Articles 98-100 on Preventive health protection measures, Good administrative practice, and electronic system for market surveillance.

Get detailed information here: https://omcmedical.com/legacy-medical-devices-requirements-in-europe/

[james675-blog1]

It is made in the European Union / have a CE mark/

Yeah you heard it right. This baby is born and raised in the old continent. Great so what can I benefit from this. 

You won’t anything, besides you can be sure the materials used are legit, you have someone who is actually accountable for the product, you are creating work in here, you get your stuff faster.

This sound more and more like the bit from the life of Brian about what the Romans did for them…

Anyway let’s dive a bit deeper on this issue, to see how deep the rabbit hole really is. We can easily say we do not support child work /obviously/ and we pay fair wage to our workers, partners. We pay taxes, so your money strengthens the EU trade. Your money stays here and being put in use. 

Furthermore, we are actually creating something out of raw material, this is not just shipping something, (which was made thousands of miles away) while putting our logo on it type of deal. which was made thousands of miles away. 

By buying a product which complies with all the European rules, regulations, standards all the way through to the smallest components. It is follows the “you either get the best there is available or you get nothing policy”. So this thing have an EC on it which means it’s officially made in the EU.

Learn how to buy motorbike usb charger online.

You are helping the environment by not buying something which made out of plastic. However, that’s a whole different story. Furthermore, you help by buying something which was made relatively close. So you are not polluting  the environment with all those kind of shipping methods. 

Since we already touched the issue of shipping we can say the product will get to you faster too, ( as long as your are in the same continent / Europe/) you can even track your package with the number we provide. So you save time too. Therefore, you won’t have to wait for days, weeks sometimes or more to get the desired product in your hands.

You are saving the environment as well. Since the distance is much shorter the carrier won’t burn as much fossil fuels as it would when it's coming from a different continent. 

What is the best phone holder for motorbike recently.

[gwendolynlerman]

Spanish vocabulary

La Unión Europea (UE) - European Union (EU)

Today, Spanish citizens of legal age vote to choose their representatives in the European Parliament, so I have decided to make a vocabulary list about the European Union. We are also voting to choose our local representatives and the representatives of our autonomous communities.

la aduana - customs

la agricultura - agriculture

la ayuda humanitaria - humanitarian aid

el Banco Central Europeo (BCE) - European Central Bank (ECB)

la bandera - flag

el cambio climático - climate change

la ciudadanía - citizenship

el comercio - trade

la Comisión Europea (CE) - European Commission (EC)

la Comunidad Ecónomica Europea (CEE/CE) - European Economic Community (EEC)

la Comunidad Europea de la Energía Atómica (Euratom) - European Atomic Energy Community (EAEC/Euratom)

la Comunidad Europea del Carbón y del Acero (CECA) - European Coal and Steel Community (ECSC)

el Consejo de la Unión Europea - Council of the European Union

el Consejo Europeo - European Council

la Constitución - Constitution

el contrato - contract

la cooperación - cooperation

la cultura - culture

la democracia - democracy

el derecho international - international law

los derechos humanos - human rights

el desarrollo - development

la dignidad - dignity

la educación - education

el empleo - employment

la energía - energy

Europa - Europe

la frontera - border

el himno - anthem

la igualdad - equality

la industria - industry

la inflación - inflation

la innovación - innovation

la institución - institution

la integración - integration

el jefe de Estado - head of state

la justicia - justice

la juventud - youth

el lema - motto

la libertad - freedom

el medio ambiente - environment

el mercado único - single market

la migración - migration

el ministro/la ministra - minister

la moneda - currency

la organización - organization

el Parlamento Europeo - European Parliament (EP)

la política - policy

la política exterior - foreign policy

el referéndum - referendum

el/la representante - representative

la salud - health

la seguridad - security

la solidaridad - solidarity

el transporte - transport

el tratado - treaty

el Tribunal de Cuentas - European Court of Auditors (ECA)

el Tribunal de Justicia de la Unión Europea (TJUE) - European Court of Justice (CJEU)

la unión monetaria - monetary union

económico - economic

internacional - international

jurídico - judicial

oficial - official

político - political

los Estados miembros - Member States

Alemania - Germany

Austria - Austria

Bélgica - Belgium

Bulgaria - Bulgaria

Chipre - Cyprus

Croacia - Croatia

Dinamarca - Denmark

Eslovaquia - Slovakia

Eslovenia - Slovenia

España - Spain

Francia - France

Grecia - Greece

Hungría - Hungary

Irlanda - Ireland

Italia - Italy

Letonia - Latvia

Lituania - Lithuania

Luxemburgo - Luxembourg

Malta - Malta

Países Bajos - the Netherlands

Polonia - Poland

Portugal - Portugal

Reino Unido - United Kingdom

República Checa - Czech Republic

Rumanía - Romania

Suecia - Sweden

[isocertificationinindia]

IMPLEMENTATION OF CE MARK CERTIFICATION

Introduction

Every customer in the world has the right and desire to purchase a product that has been certified as safe or is safe. The CE Mark Certification in India is displayed on products that are related to health, safety, and the environment. It was developed in Europe. The European Economic Area, also known as the EEA, is a regulatory body in Europe. The EEA certifies the quality of the products on its list. Products manufactured within the European Economic Area are required to have the CE certification mark. Both importers and the product's maker must confirm that products with the EC marking agree to the rules.

European nations like Iceland, Liechtenstein, and Norway are included in the EEA. The EEA single market is another name for it. The CE refers to the "Conformite Europeenne". The term "CE" originally stood for "European Conformity," but in 1993 it was modified to "CE mark." As the EEA standards constitute a symbol of assurance, products exported to the EEA from other nations may also have the CE marking.

What is CE Marking? 

Since 1985, the European Union (EU) has required mandatory conformity marking for products sold inside the European Economic Area (EEA). This is known as the Conformitè Europenne (CE) Mark. The CE marking represents a manufacturer’s assurance that items conform to the EU’s New Approach Directives. These directives include both products made in or intended for sale in the EEA as well as those that are sold in the EU. As a result, the CE symbol is recognized everywhere, even by people who are not familiar with the EEA.

What Does the CE Marking Indicate?

The CE marking for electronic and electrical products is a type of standardization mark that denotes compliance with health, safety, and environmental protection standards. The Logo has significant value as a standard that individuals can trust, and to enhance that trust, the CE technical experts are gradually adjusting to the shifting trends of various products and raising the requirements for passing the level. They also assist the manufacturers as advisors. Because many items are sold outside of the EEA, CE is a standard international standard.

Benefits of CE Certification for Manufacturers and Final Users:

The CE certification is the internationally recognized standard for the product's safety and protection. The CE mark is used to identify goods produced under the jurisdiction of European Directives and Regulations, and they can be legally marketed on the international market. CE Certification in Indonesia In addition to serving as a symbol of quality assurance, CE marking enables a producer to certify that the product was created in accordance with European Union product safety regulations and is safe to use under the specified operating environments. Give assurance regarding protection and safety to every product, but especially electrical products, which have some hidden risks that could become obvious with time. Its exposure is more likely to have an impact on those who use it more regularly. The users are guaranteed the highest level of safety and protection thanks to the CE logo on the product. From a safety and protection standpoint, the product will remain genuine and risk-free as long as the consumer uses it as per the instructions. It is one of the major benefits of CE certification. The CE certification is the internationally recognized standard for the product's safety and protection. The CE mark is used to identify goods produced under the authority of European Directives and Regulations, and they can be legally marketed on the international market. In addition to serving as a symbol of quality assurance, CE marking enables a producer to guarantee that the product was created under European Union product safety regulations and is safe to use under the specified operating environments. Manufacturers operating under EU directives who do not need to make their products conform to various regulations should use standardized marking. All manufacturers in the EEA now have uniform guidelines according to EU directives. This assists the producers and traders in resolving disputes between states over the rules. To make goods for their different markets, manufacturers no longer need to implement distinctive rules. If a manufacturer's products are subject to CE requirements, they must get CE certification. On the other hand, applying the CE marking is illegal if the product is not covered by the specified guidelines. Remember that not all product categories are subject to the same laws and rules. The product could be subject to more than one regulation. If you are unclear whether a specific directive applies to your product or not, feel free to review the directive's definition and scope. To ascertain whether a product is excluded from the act, you can also evaluate the exception that is not taken into consideration by the regulation. 

How to obtain the CE mark certification?

It is completely your obligation as the product's manufacturer to certify compliance with all regulations. Permission is not required to apply the CE Mark Certification in Egypt to your goods. However, you must first fulfill the responsibilities:

Ensure compliance with all relevant EU regulations.

You must decide whether you can evaluate your product individually or if a notifying body is required. A technical document demonstrating conformance was created. When searching for documentation, examine technological documentation.

compose and sign a declaration of compliance with EU standards.

Establish a compliance folder for the product that contains all the documentation proving that it conforms with the rules, such as testing results, risk assessments, etc.

If the relevant national authority requires it after your product has the CE mark, you must give them all the relevant data and associated documentation.

Important CE marking considerations for importers and distributors

Importers:

Importers must confirm that the item they put on the market satisfies the required specifications. They should make sure that the item is not harmful to the citizens of Europe. Importers should verify that the manufacturer has completed all necessary actions and that any required documentation is available. 

Distributors:

They need to have basic knowledge of the legal standards for CE-marked products and the required documents. Products that fail to conform to safety should be identified in the documentation. They must be able to prove to the national authorities that they took the necessary precautions and have the product verified by the manufacturer.

Conclusion 

One of the best and most respected standards is CE Marking, which enables the producer to utilize the mark to relax the requirements. The European Economic Area is open to free trade and the transportation of goods. Most products should have the CE mark for you to expand your company and sell your goods on the European market. For a business that aims to retain quality for its clients, we are among the best suggestions for planning, consulting, and auditing. Bringing trustworthiness certification is one of the good assets that we are trying to make for our customers with a proper producer. 

[popedenique]

What is CE marking? Why CE Marking Certification Is Necessary?

What is CE marking?

CE Marking is a certification that determines product conformity with health, safety and environmental protection standards.  CE marking applies to product sold within the European economic area (EEA). The CE marking can also be found on products that are sold outside the European economic area but are manufactured or designed in the EEA. CE Marking Certification is also known as CE mark. CE marking certification is mandatory to export products to Europe. The CE marking on a product the manufacturer ensures that the product is in conformity with the essential requirements of the applicable EC directives. The Word "CE" stand for "Conformite Europeene" ("European Conformity"). According to the level of risk of the product, the CE Mark is affixed to a product by the manufacturer or authorized representative after ensuring that the product meets all the CE mark requirements.

Why CE Marking Certification Is Necessary?

CE marking certification for a product is necessary in a number of ways, some of which are listed below.

CE marking Certification on a product gives guarantees that the product is in compliance with the necessary requirements of the European health safety and environmental protection legislations.  It gives more credit and confidence to the manufacturers to push their products to the global market.

CE marking certification on a product also gives assurance to government officials that the product is fit enough to be placed on the market in their country, and thus enhancing global distribution of products

CE marking certification on a product also aids easy and free movement or distribution of a product within the European Union market; it also permits the withdrawal of the products that does not conform with the EEA customs and enforcement authorities or regulations.

CE Marking Process

To apply the CE marking product certification, you need to set up a technical dossier showing that your product fulfills all the EU-wide prerequisites. Being the product's manufacturer, you bear exclusive obligations for ensuring conformity with all requirements. Some of the processes for CE marking are:

Take enquiry about the EU requirements (applicable directive / rule) for your CE Marking

Product.

Check whether your CE product meets the specific requirements for CE Marking Certification.

Check whether your CE product needs to be tested by a Notified Body

Test your CE Marking product personally & subsequently from external agency (If required for your product).

Arrange the technical file / technical dossier / technical construction file.

Affix the CE marking and draft a declaration of conformity (EU Declaration of conformity / EC Declaration of conformity.

Countries Where CE Marking is Mandatory

CE Marking is mandatory in following European countries:

Estonia, Finland, France, Germany, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom, Turkey, Netherlands, Poland, Portugal.

Apart from above specified countries many Asian, African & Middle East countries accept CE Marking as a parameter of product safety.

HOW DO YOU BENEFIT FROM CE MARKING CERTIFICATION?

The CE marking Certification is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 countries of the European Economic Area (EEA).

The benefit for CE manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire EEA. The various and conflicting national regulations are eliminated. As a result, the product no longer needs to be adapted to the specific requirements of the different member states of the EEA.

Similarly, In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims.

IAS Expertise in CE Marking Services

    IAS certification is an accredited certification registrar providing different types of certificate which include the CE marking certificates for various organizations or companies.  Our Organization (IAS) expertise in the industry is second to none as we boast of best hands that have gotten relevant experience in CE marking services. Should you need to get CE marking in India, don't hesitate to reach out to us at IAS certification limited. EAS mainly focusing to conduct audit and ensure everything is properly placed towards getting your CE mark certification.

IAS offer a comprehensive CE marking services and our process is simple and easy. Similarly with, good customer relationship and awesome attention to details, we believe you will have a nice and wonderful experience working with us. In our Organization, technical experts are highly qualified to guide you in every step of CE Marking process. We have given CE Marking services to every size of organization in India & abroad. We at IAS make CE Marking Process very simple for you through our proper guidance. Right from identification of applicable EU directives, selection of CE certification module, arranging CE Mark testing services, preparation of CE Marking Technical file, till making of 'EU Declaration of Conformity' & grant of CE Certificate, Our Company IAS help you on every step.

We offer is simple, good old fashioned honesty, complete integrity, ultimate professionalism and exceptional customer service. It is our belief that just being good at what we do is not good enough. Our services have to be better than our competitors and from what we hear from our clients, it is. We believe that by working closely with our clients, we can provide the consistent, dedicated and honest service you deserve, is a world leading CE Marking company. We have more than 20 years’ experience in CE marking services in India & worldwide. With a wide network of offices IAS is able to provide you CE Certification services in all parts of India & abroad also.

CE Marking Certification Provider:

To get an CE Marking &Certification choose best company.

Don’t wait for clients to come and knock on your door for  

Be proactive – don’t trust in luck. Work and develop your qualifications, choose your target clients and make yourself known. To track your progress and evaluate the effectiveness of your actions, consider making a business plan with targets for number of clients and revenue.  Choose a right CE marking certification

[pranalipawarshinde]

Aptamer Market Trends and Competitive Analysis Report 2017-2025

Aptamer Market: Overview

The global aptamer market was valued at approximately US$ 1.0 Bn in 2016 is projected to register cumulative annual growth rate (CAGR) of over 20.0% from 2017 to 2025, according to a new report published by Transparency Market Research (TMR) titled “Aptamer  Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2017–2025”. The report suggests that surge in interest of research activity in the field of aptamer technology is likely to spur the demand of aptamer in the coming years (2017 to 2025). As key players introduce their new aptamer services for different application in developed markets such a North America and Western Europe, these regions are likely to account for dominating share of the global aptamer market. Demands for new diagnostic assay and increasing research activity in emerging markets such as China and Japan is likely to boost growth of Asia Pacific aptamer market at a CAGR of around 21.0% from 2017 to 2025.

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Inadequate Regulatory Policies and Ethical Issues Related To Aptamer Development Can Restrain Global Market Expansion

Aptamer can be used as alternative to antibodies for various application. There is no formal regulatory guideline, which specifically addresses the quality expectation of aptamers. The regulatory expectation of aptamer-based drugs is still evolving. Several countries in Europe have tedious documentation processes for starting clinical trials of aptamers. For example, in Europe, the EU Clinical Trial Directive 2001/20/ EC is mandatory for initiation of aptamer clinical trials. However, the region has not developed any oligonucleotide specific guideline that can address the general requirements for the quality of aptamer clinical trials. Moreover, lack of universal rules for the application of aptamers in bioassays, which is well established when working with antibodies, restrains growth of global aptamer market.

Other Selection Techniques (e.g. X- Aptamer, MARAS etc.) to Lose Market Share

The report offers detailed segmentation of global aptamers market based on material type, selection technique and applications. Among the selection technique studied, SELEX technique segment is poised to account for leading share of the global market during the forecast period from 2017 to 2025. SELEX technique is likely to get boost for the modification of existing SELEX process, and available of the new updated SELEX technique like CE-SELEX, M- SELEX etc. which overcome the certain limitation for aptamer selection. The other technique (X-aptamer, MARAS technique etc.) segment is anticipated to lose its market share during the forecast period, and is expected to hold a share of ~18.0% by 2025 from ~21% in 2016. Availability of upgraded SELEX technique and lack of selection of high affinity ligands as compare to SELEX technique are factors likely to hamper this segment.

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Diagnostics & Research: Top Two Application Areas of Aptamer

Among applications, research segment is projected to hold dominant share of global aptamer market during the forecast period and is likely to expand at CAGR more than 21.0% from 2017 to 2025. Major factors responsible for the dominance of this segment are efforts by several key players to develop new aptamers for research and development applications. For example, Aptagen, LLC has developed aptabodies (patent pending) that overcome the limitation of traditional pharmaceutical drug discovery process. The Aptabody technology demands shorter development time and offers effective Adsorption, Distribution, Metabolism and Excretion (ADME) properties due to unique chemical properties. Aptabodies are formed by hybridization of two DNA aptamers and allow detection of human thrombin effectively compared to traditional aptamers. In addition, aptabodies represent new area of development for next generation pharmaceuticals with improved pharmacokinetics and pharmacodynamic. Diagnostics segment, accounted for more than 30.0% share of global aptamer market in 2016, in terms of value. It is anticipated to have substantial growth and account for approximately 33.8% of market share by 2025.

Asia Pacific to Resister Exponential Growth and Offer Huge Incremental Opportunity

In terms of value, North America was leading contributor in global aptamer market in 2016. High level of research activity in the U.S. is one of the contributing factor for major share of the North America market. Furthermore, presence of several key players such as Aptagen, Inc., Regado Biosciences, Inc. and Somalogic, Inc. has resulted in increased investment in research and development of novel aptamers. Thus, presence of these players would help the aptamers market in North America to grow rapidly during the forecast period Pharmaceutical research and development spending in emerging markets such as China and India are rising, which is fueling the expansion of Asia Pacific aptamer market. Regaining economic growth in Latin American markets such as Brazil is augmenting research and development activity, spending is increasing in diagnosis and treatment of various diseases in this region. This factor is likely to propel Latin America cardiovascular drugs market at CAGR of 19.0% from 2017 to 2025.

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Key Players such as Somalogic, Inc., Aptagen, Inc, and Aptamer Group Limited are Likely to Continue to Lead the Global Aptamer Market

The report also provide profiles of leading players operating in global aptamer market include AM Biotech, Aptagen, LLC., Aptamer Group, Aptamer Sciences, Inc., Base Pair Biotechnologies, CD Genomics, NeoVentures Biotechnology Inc., NAXXON Pharma, Aptus Biotech, TriLink BioTechnologies, LLC., and Pfizer Inc. Expansion of aptamer based products portfolio through improving existing drugs and developing new drug molecules is one of the key strategy adopted by many key players, recent developing drugs such as NOX-E36 for treating type 2 diabetes by NAXXON Pharma and other key players reflect these strategies.

More Trending Reports by Transparency Market Research:

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About Us

Transparency Market Research (TMR) is a market intelligence company, providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants, use proprietary data sources and various tools and techniques to gather, and analyze information. Our business offerings represent the latest and the most reliable information indispensable for businesses to sustain a competitive edge.

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