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 since 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…

MDCG 2023-3: Questions and Answers on vigilance terms and concepts as...

The Medical Device Coordination Group (MDCG) has published the MDCG 2023-3 guide, which aims to clarify important terms and concepts (...)

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Extension of transition period for medical devices and in vitro diagnostic...

The amendment that modifies Regulations (EU) 2017/745 and (EU) 2017/746 with respect to transitional provisions for certain medical devices (MD) (...)

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Your certification projects for medical devices incorporating a medicinal substance under...

GMED has extensive experience with a team specialized in assessing medical devices incorporating medicinal substances under Regulation (EU) 2017/745 (analyzing (...)

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MDCG 2023-1: Guidance on the health institution exemption under Article 5(5)...

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2023-1 which aims to support a harmonised application of (...)

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European Commission Newsletter on medical devices | December 2022

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

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Dr. Duncan McPherson appointed to WHO expert group on medical devices

Dr Duncan McPherson, who recently joined LNE-GMED UK as internal clinician, has been appointed as a member of the first-ever (...)

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Proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746

The European Commission has adopted a proposal for a regulation amending the transitional provisions of Regulations (EU) 2017/745 and (EU) (...)

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Best wishes 2023

3, 2, 1… Happy New Year! From Paris to Washington D.C. through London, the GMED group teams line up today (...)

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

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Upcoming Events

Apr 06 - 07, 2023 Training | Virtual Classroom

Risk Management Applied to Medical Devices (ISO 14971:2019)

May 01 - 05, 2023 Training | Virtual Classroom

Medical Device Single Audit Program (MDSAP) for Manufacturers

May 09 - 10, 2023 Training | Virtual Classroom

European in Vitro Diagnostic Devices Regulation (EU) 2017/746