GMED, dedicated to Health and Innovation in Medical Devices

For over 30 years, we have been assessing the conformity of medical devices and quality systems enabling medical device manufacturers to place their products on the market worldwide.

Our expertise in offering training courses tailored to your needs, the development of high-value technical and regulatory content and the support provided throughout your certification cycle are all available assets for your projects success.

Whatever the level of risk or innovation of your device, whether implantable, custom-made, electromedical, in vitro diagnostic, or other… Choose GMED, its subsisdiaries and its parent company, LNE, and have the reputable and recognized organizations in the field of certification and testing as your strategic partner.

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Notified Body & Certification Body in the Health Care and Medical Devices Industry

Whether part of a voluntary certification process or within a regulatory framework, we combine your various certification needs for maximum efficiency, addressing the conformity and quality challenges you face.

Our teams of experts, exclusively dedicated to the medical devices industry in Europe, Asia and North America, and our proven methodology make GMED an international reference body.

>30
years of experience
350
people dedicated to certification
+66%
growth in personnel in 5 years
Service

Certification

Whatever your company’s size or location, and whatever the category of your medical device, you will find at GMED and its subsidiaries services and expertise matching your product and/or quality management system (QMS) certification needs.

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Service

Training

GMED North America’s Training Center makes its expertise readily available to develop your company resources.

Our training courses, both in person and online, are designed to help your teams acquire the knowledge needed to successfully achieve your company goals in terms of risk management, and implementation of the EU Regulations on medical devices.

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LNE Service

Medical Device Testing

Testing your medical devices to ensure conformity with applicable technical standards

Service

Focus on Medical Devices

Delivering technical and regulatory information in key medical device fields:

Working at GMED

Unleash your potential, leverage your expertise and be part of a dynamic, flexible team at a human-centered company.

Research by using microscope

News

View all our technical, regulatory and normative information including guides, webinars, news…

Application for certification under Regulation (EU) 2017/745

This guide presents the key stages of the certification process under Regulation (EU) 2017/745 set up by GMED. It guides (...)

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European Medicines Agency Q&A guidance on the implementation of the MDR...

The EMA has updated its Q&A guidance on the implementation of EU regulations for medical devices and in vitro diagnostic medical (...)

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5th revision of the MDCG 2019-6: Q&A on the requirements relating...

The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR (...)

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Latest European Medical Device Nomenclature update

The annual revision of the EMDN ensures that MD nomenclature incorporates the latest innovations, ensuring accurate classification. These updates ensure (...)

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Phthalates in medical devices: regulations and alternatives

Since the early 2000s, particularly in Europe, there has been a growing awareness of the impact of chemical substances on (...)

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Heading for 2025: Best wishes from the 4 corners of the...

From Paris to Washington D.C., via London and Hong Kong, all our teams would like to thank you for the (...)

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MDCG 2024-16: Form and Annex for manufacturer’s information on the interruption...

The MDCG has just published a form for manufacturers to report interruptions or discontinuation of the supply of certain IVDs (...)

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Q&A on gradual roll-out of EUDAMED

The European Commission has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed (...)

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News

View all our technical, regulatory and normative information including guides, webinars, news…

Visit the Knowledge Center

Upcoming Events

Jan 28 - Feb 27 Training | Virtual Classroom

Bundle: European Medical Devices Regulation (EU) 2017/745 & Technical Documentation per Medical Devices (EU) 2017/745

Feb 25 - 27, 2025 Training | Virtual Classroom

Technical Documentation per Medical Devices Regulation (EU) 2017/745

Mar 04, 2025 Training | In-Person Classroom

Post Market Surveillance and Vigilance