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…

GMED at RAPS Convergence 2026

Join Us at RAPS Convergence 2026 in Charlotte GMED is pleased to announce that we will be exhibiting at the (...)

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The MedTech Conference 2026

The global gathering for medtech returns to Boston, MA, October 18–21, 2026. Hosted by AdvaMed® (The Medtech Association), #MTC26 brings (...)

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Changes to devices and/or quality management system: When and how to...

The purpose of this medical device change notification guide, developed by GMED, is to provide guidance on when and how (...)

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Codes assignment as part of a certification application under Regulation (EU)...

Commission Implementing Regulation 2017/2185 establishes the codes assignment MDR framework. This framework defines notified bodies’ scope of designation for medical (...)

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MDCG 2021-12 Rev2: EMDN FAQ update

The MDCG has published Revision 2 of the MDCG 2021-12 guidance, dedicated to the FAQ on the European Medical Device (...)

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Article 10a MDR / IVDR : New guidance documents

The European Commission has published updated reference documents related to Article 10a of the MDR and IVDR, addressing the information (...)

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New MIR v7.3.1 form – MD & IVD vigilance

The European Commission has released an updated Manufacturer Incident Report (MIR) form. The use of MIR version 7.3.1 becomes mandatory (...)

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MDCG 2026-1: Summary of the EMDN annual revision outcomes

The MDCG 2026‑1 provides an overview of the EMDN update requests submitted in 2025, together with the decisions taken following (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Jun 16 - 17, 2026 Training | Virtual Classroom

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

Jun 23 - 24, 2026 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745

Jun 24 - 26, 2026 CMEH | Shangai, China

Shanghai International Medical Devices Exhibition 2026