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…

Guidance MDCG on classification for IVD MD under Regulation (EU) 2017/746

The Medical Devices Coordination Group (MDCG) has published a Guidance document MDCG 2020-16 on Classification Rules for in vitro Diagnostic (...)

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European Commission publication on EUDAMED and the module on economic actors’...

The European Commission has recently published on its website information dedicated to EUDAMED and more specifically information related to the (...)

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The main changes introduced by the “MDSAP AU P0002.005 Audit Approach”...

On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the (...)

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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 Implementing Regulation (EU) 2020/1207 of the European Commission of August...

The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020, published in the Official Journal, lays down (...)

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MDCG Position paper on the use of the EUDAMED actor registration...

The Medical Devices Coordination Group (MDCG) has just published a position document on the use of the EUDAMED actor registration (...)

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European Commission updated FAQs on Unique Device Identification (UDI)

The European Commission has just published an updated FAQ covering 16 key questions regarding the Unique Identification System (UDI) under (...)

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Commission guidance for the medical devices expert panels on the consistent...

The European Commission has just published in its Official Journal a text named “Commission guidance for the medical devices expert (...)

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News

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

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