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.


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.

years of experience
people dedicated to certification
growth in personnel since 2019


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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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


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


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

Regulation (EU) 2024/1860: Extension of the IVDR transitional period and other...

The Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) has been published in the Official Journal (...)

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MDCG 2024-10 guidance on clinical evaluation of orphan medical devices 

Published on June 25, 2024, the MDCG 2024-10 guidance on the clinical evaluation of ‘orphan devices’ clarifies the criteria for (...)

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GMED leadership evolves

GMED is pleased to announce the arrival of Romuald Gorjup as Certification Director at the French entity GMED SAS. Romuald (...)

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

Visit the Knowledge Center

Upcoming Events

Aug 08, 2024 Training | Virtual Classroom

Post Market Surveillance and Vigilance

Aug 13 - 14, 2024 Training | Virtual Classroom

The Clinical Evaluation Requirements (CER) under the EU MDR 2017/745

Aug 20 - 21, 2024 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745