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.

Research by using microscope


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

Publication of a Team-NB position paper on changes affecting the device...

Team NB has published on its website a position paper about substantial changes impacting the device component of a drug (...)

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Best wishes 2021

It is a particular and unprecedented year which has just ended…The mobilization and adaptability of all have made it possible (...)

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MDCG summary document on UDI assignment for Spectacle lenses & Ready...

The Medical Device Coordination Group (MDCG) has just published a summary document on the UDI assignment (Unique Device Identifier) for (...)

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EUDAMED: Launch of the economic actors’ registration module

The European Commission has recently rolled out the first EUDAMED module called “Actor registration module” and intended for economic operators: (...)

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Guidance MDCG on classification for IVD MD under Regulation (EU) 2017/746

The Medical Devices Coordination Group (MDCG) has published a Guidance document MDCG 2020-16 on Classification Rules for in vitro Diagnostic (...)

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European Commission publication on EUDAMED and the module on economic actors’...

The European Commission has recently published on its website information dedicated to EUDAMED and more specifically information related to the (...)

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

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Upcoming Events

Jan 28, 2021 Training | Virtual Classroom

Post Market Surveillance and Vigilance New Requirements under the European Medical Device Regulations

Feb 25 - 26, 2021 Training | Virtual Classroom

Medical Device Single Audit Program (MDSAP) for Manufacturers

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