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
310
people dedicated to certification
+41%
growth in personnel since 2019
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…

Tom Patten, IVD International Manager for the GMED Group

We are pleased to announce that Tom Patten has joined the GMED Group as IVDR/IVD International Manager. Tom also brings (...)

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European Commission Newsletter on medical devices | May 2024

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)

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Artificial intelligence, the heart of our stakes

LNE, GMED’s parent company, and INRIA have just signed a framework agreement defining their roadmap, with the aim of setting (...)

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The MHRA announced a framework for international recognition of medical devices

LNE-GMED UK, as an Approved Body, collaborates with Team-AB and the MHRA to streamline the pathway for medical devices in (...)

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GMED at MedtecLIVE

  GMED will be exhibiting at MedtecLIVE from June 18 to 20 in Stuttgart, Germany. MedtecLIVE, Europe’s leading trade fair (...)

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GMED NA at RAPS
Convergence 2024

Join us in Long Beach, California from September 17 to 19 for RAPS Convergence 2024, the premier event for regulatory (...)

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Do you market class I medical devices under the Directive, which...

According to Regulation (EU) 2023/607, you have to submit an application for certification to a notified body before the May (...)

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The leadership of LNE-GMED UK is evolving

Teresa Perry has held the position of Branch Director and Head of Approved Body at LNE-GMED UK since May 1st, (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Jun 10 - 14, 2024 Informa | Brussels, Belgium

MedTech Summit 2024

Jun 19 - 20, 2024 TT LifeSciences | Boston, MA

US Annual Medical Device and Diagnostic Post-Market Surveillance & Vigilance Conference

Jun 19 - 20, 2024 Training | Virtual Classroom

Systematic Literature Review for Medical Devices

Identify, appraise and analyze available clinical data from relevant scientific literature on a medical device