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.

Research by using microscope


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

Article 61(10) of Regulation (EU) 2017/745: Instructions for use and FAQ

According to Article 2(44) of the Medical Devices Regulation (EU) 2017/745 (MDR), clinical evaluation is defined as a “systematic and (...)

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The European Commission guidance on the content and structure of the...

On May 8, 2023, the European Commission has published its guidance on the content and structure of the summary of (...)

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1st revision of the guidance MDCG 2020-3 on significant changes regarding...

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 (...)

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Q&A on the practical implementation of Implementing Regulation (EU) 2023/607 amending...

The European Commission has published on the European Commission’s website a Q&A to facilitate the practical and homogeneous implementation of (...)

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European Commission Newsletter on medical devices | March 2023

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

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

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Upcoming Events

Jun 15 - 16, 2023 Training | Virtual Classroom

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

Jun 19 - 20, 2023 Training | Virtual Classroom

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

Jun 28, 2023 Training | Virtual Classroom

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