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…

New harmonised European standards under Regulation (EU) 2017/745

The European Commission has published in the Official Journal of the European Union the Implementing Decision (EU) 2022/6 which amends (...)

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MDCG 2021-28: Model notification form for substantial modification of clinical investigation...

The sponsor of a clinical investigation is required to notify the Member States in which a clinical investigation is or (...)

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Instructions for Electronic use of medical devices: Publication of the Implementing...

On December 15, 2021, the European Commission published in the Official Journal the Implementing Regulation (EU) 2021/2226 on rules for (...)

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Best wishes 2022

GMED wishes everyone a happy new year 2022! Thank you to our customers for their trust, our partners for their (...)

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EUDAMED: The Official Journal of the European Union has published the...

On November 29th, 2021, the European Commission published in the Official Journal the commission implementing regulation (EU) 2021/2078 laying down (...)

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Biological evaluation: chemical characterization according to EN ISO 10993-18:2020

The purpose of the medical device is to provide a benefit to the patient, directly or indirectly, by allowing the (...)

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Creation of LNE-GMED UK subsidiary: LNE group increases its international presence

The LNE group is expanding its certification activities in the UK by setting up a new subsidiary: LNE-GMED UK. 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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News

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

Visit the Knowledge Center

Upcoming Events

Jan 25 - 26, 2022 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745

Feb 14, 2022 Training | Virtual Classroom

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

Mar 01, 2022 Training | Virtual Classroom

Post Market Surveillance and Vigilance New Requirements under the (EU) MDR/IVDR