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 training
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 careers

News

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

Version 5 of Manual on borderline and classification for MDs and...

A new version of the Manual on Borderline and Classification under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) has been (...)

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IVDR Class C: Why “Application Submitted” is not enough

A valid Class C application is necessary to maintain your transitional timeline — but it is not, by itself, sufficient (...)

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MDCG 2021-24 Rev.1 Guidance on Medical Device Classification

The Medical Device Coordination Group (MDCG) has published Revision 1 of MDCG 2021‑24, the guidance dedicated to the classification of (...)

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New EU Harmonized Standards for Medical Device Sterilizers, Steam Boilers and...

The European Commission has published Implementing Decision (EU) 2026/760, updating the list of harmonized standards supporting compliance with the Medical (...)

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AMDM IVD Regulatory Submissions Workshop

GMED at AMDM’s IVD Regulatory Submissions Workshop 21 April 2026 | North Bethesda, MD, USA GMED is pleased to announce (...)

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OSMA 2026 Spring Meeting

GMED at the 2026 OSMA Spring Meeting 21–23 April 2026 | Washington, D.C. GMED is pleased to announce that it (...)

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EUDAMED : Prepare for Mandatory Implementation

EUDAMED becomes mandatory on 28 May 2026, with four modules now declared fully functional by the European Commission. This marks (...)

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RWE-Driven MedTech: Cross-Sector Perspectives on Building Cost-Effective Clinical Evidence Strategies

GMED will participate in the Spring Symposium 2026, titled “RWE‑Driven MedTech: Cross‑Sector Perspectives on Building Cost‑Effective Clinical Evidence Strategies.” Organized (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Apr 29, 2026 3Aware | Webinar

RWE-Driven MedTech: Cross-Sector Perspectives on Building Cost-Effective Clinical Evidence Strategies

Apr 28 - 29, 2026 Training | Virtual

Biocompatibility of Medical Devices

May 05 - 06, 2026 Training | Virtual Classroom

Cleanliness of Newly Manufactured Medical Devices