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.

structure
70
84
10
10
10
10
10
10
10

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…

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 (...)

Learn more

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 (...)

Learn more

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 (...)

Learn more

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 (...)

Learn more

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 (...)

Learn more

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 (...)

Learn more

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 (...)

Learn more

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 (...)

Learn more

News

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

Visit the Knowledge Center

Upcoming Events

May 05 - 06, 2026 Training | Virtual Classroom

Cleanliness of Newly Manufactured Medical Devices

May 05 - 08, 2026 RAPS | Lisbon, Portugal

RAPS Euro Convergence 2026

May 11 - 13, 2026 HKTDC | Hong Kong, China

Hong Kong International Medical and Healthcare Fair