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.

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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 France, Europe and North America, and our proven methodology make GMED an international reference body.

25
years of experience
+220
people dedicated to certification
+20%
growth in personnel in 2019
Service

Certification

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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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.

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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.

Research by using microscope

News

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

Biological assessment of medical devices according to the ISO 10993-1 standard

The GMED teams have prepared this document in an aim to guide the medical device manufacturers in the presentation and (...)

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The European Commission proposes a gradual implementation of the European Regulation...

The unprecedented challenges posed by the COVID-19 pandemic have diverted the resources of Member States, health institutions, and economic operators (...)

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MDCG 2021-24 Medical Device Classification Guidance

The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-24 guide. This document is intended to help manufacturers (...)

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On November 16th, GMED is organizing its IVDMD Forum: Implementation of...

This new digital edition will bring together on a TV studio our speakers who will address several topics including the (...)

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EUDAMED: New modules available

The modules: “Unique Device Identification (UDI)” and “Notified Bodies & Certificates” are now available in EUDAMED. Economic operators and notified (...)

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Application request for CE marking certification – Regulation (EU) 2017/745

This guide specifies the main steps of the certification process implemented by GMED according to the requirements of Regulation (EU) (...)

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Expert panels for IVDMDs

The European Commission’s website indicates that the expert panels for in vitro diagnostic medical devices is now accepting submissions from (...)

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MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification...

The Medical Device Coordination Group has published the MDCG 2021-23 guidance. This guidance is intended to provide assistance to notified (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Oct 27 - 28, 2021 Training | Virtual Classroom

Medical Device Electrical Safety (IEC 60601-1 3rd Edition)

IEC 60601-1 3rd Edition represents the benchmark for medical electrical equipment and compliance to the standard is a requirement in many countries including Europe (EN 60601-1:2006)

Nov 01 - 02, 2021 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745

Nov 03, 2021 Training | Virtual Classroom

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