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
310
people dedicated to certification
+41%
growth in personnel since 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 2022-16 on Authorized Representatives Regulation (EU) 2017/745 on medical...

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2022-16 for authorized representatives, manufacturers, and other economic operators. (...)

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Your certification projects for medical devices incorporating a medicinal substance under...

GMED has extensive experience with a team specialized in assessing medical devices incorporating medicinal substances under Regulation (EU) 2017/745 (analyzing (...)

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Current MHRA position regarding transitional requirements to the future regulation of...

On 21st October 2022, the Medicines & Healthcare products Regulatory Agency (MHRA) has just informed the industry stakeholders of a (...)

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Guidance MDCG 2022-15 on appropriate surveillance regarding the transitional provisions under...

The MDCG (Medical Devices Coordination Group) published the guidance MDCG 2022-15 on the appropriate surveillance to be conducted by Notified Bodies (...)

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In vitro diagnostic software: Novelties introduced by Regulation (EU) 2017/746

Regulation (EU) 2017/746 on in vitro diagnostic medical devices came into force on May 26, 2022. Among the novelties introduced (...)

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European Commission Newsletter on Medical Devices | September 2022

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)

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Ava Sainter, IVD Product Reviewer, LNE-GMED UK

We are pleased to announce that Ava Sainter has joined our LNE-GMED UK subsidiary as an in vitro diagnostic (IVD) (...)

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Manual on borderline and classification for medical devices under Regulation (EU)...

The Borderline and Classification Working Group has just published on the European Commission website the Manual on borderline and classification (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Nov 29 - 30, 2022 Training | Virtual

European Medical Device Regulation (EU) 2017/745

Dec 01 - 02, 2022 Training | Virtual

Medical Device Electrical Safety (A Review of IEC 60601-1/A2)

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)

Dec 02, 2022 Training | Virtual Classroom

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