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.

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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.

>30
years of experience
350
people dedicated to certification
+66%
growth in personnel in 5 years
Service

Certification

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.

Medical Device certification
Service

Training

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.

Medical Device certification
LNE Service

Medical Device Testing

Testing your medical devices to ensure conformity with applicable technical standards

Service

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.

Medical Device certification

News

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

GMED at The MedTech Forum 2025

GMED will be at the MedTech Forum, Europe’s leading healthcare and medical technology conference. Come meet our team at booth (...)

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4th revision of MDCG 2020-16 guidance on the rules for classification...

The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules (...)

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Publication in the OJEU of Regulation (EU) 2025/327 on the European...

Regulation (EU) 2025/327 on the European Health Data Space (#EHDS) and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 was published (...)

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MDSAP Program: Principles, implementation and advantages

The Medical Device Single Audit Program (MDSAP) initiative started in 2012 and has been fully operational in 2017. Since then, (...)

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2nd call launched by the European Commission for applications for EURLs...

In February 2025, the European Commission, after consultation with the Member States in the Medical Device Coordination Group (MDCG), launched (...)

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RAPS DC/Baltimore Chapter: Unlocking the Potential of MDSAP – Quality, Regulatory,...

GMED North America is hosting a RAPS DC/Baltimore Chapter in-person event on June 5, 2025, between 4:30 and 7:00 p.m. (...)

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European Commission Newsletter on medical devices | February 2025

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

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GMED at RAPS Euro Convergence 2025

GMED will be back at RAPS Euro Convergence in 2025! From May 14-16 in Brussels (Belgium), join Julien Bouclon, Sales (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Mar 27, 2025 AKRA TEAM & MedTech Leading Voice

Practical Approach to Implementing LEAN Strategies for QMS Optimization

Mar 24 - 28, 2025 Training | Virtual Classroom

Medical Device Single Audit Program (MDSAP) for Manufacturers

Apr 01 - 02, 2025 Training | Virtual Classroom

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