GMED, dedicated to Health and Innovation in Medical Devices

For over 25 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 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 France, Europe and North America, and our proven methodology make GMED an international reference body.

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


Whatever your company’s size or location, and whatever the category of your medical device, you will find GMED’s 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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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.

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

The main changes introduced by the “MDSAP AU P0002.005 Audit Approach”...

On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the (...)

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Biological assessment of medical devices according to the ISO 10993-1 standard

The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation and (...)

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The Implementing Regulation (EU) 2020/1207 of the European Commission of August...

The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020, published in the Official Journal, lays down (...)

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MDCG Position paper on the use of the EUDAMED actor registration...

The Medical Devices Coordination Group (MDCG) has just published a position document on the use of the EUDAMED actor registration (...)

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European Commission updated FAQs on Unique Device Identification (UDI)

The European Commission has just published an updated FAQ covering 16 key questions regarding the Unique Identification System (UDI) under (...)

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Commission guidance for the medical devices expert panels on the consistent...

The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert (...)

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Medical Devices Clinical Evaluation – Summary of Safety and Clinical Performance...

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the (...)

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GMED designated under Regulation (EU) 2017/745 on medical devices

GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency (...)

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

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Dec 01 - 02, 2020 Training | Virtual Classroom

Medical Device Single Audit Program (MDSAP) for Manufacturers

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