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.

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

30
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 at GMED and its subsidiaries 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…

GMED and LNE at Medi’nov

From April 3 to 4 at the Lyon Convention Center, join the GMED and LNE teams for the latest edition (...)

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LNE-GMED UK is one of the founding members of Team-AB, the...

In the evolving regulatory context in Great Britain, a group of UK Approved Bodies formed “Team-AB” in February 2024. This (...)

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GMED at the MedTech Meetup

    Meet our team at the 7th edition of the MedTech Meetup, on March 14 in Brussels. Hosted by (...)

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Publication of guidance MDCG 2024-1 and ancillary guidances MDCG 2024-1-1, MDCG...

The Medical Device Coordination Group (MDCG) has just published new guidances that describe how to report to competent authorities incidents (...)

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LNE-GMED UK designated under UK Medical Devices Regulations 2002

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has been designated as an Approved Body under the (...)

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Publication of tables summarising the language requirements applicable in each Member...

The European Commission has published on its website tables listing all the language requirements mentioned in Regulations (EU) 2017/745 (MDR) (...)

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1st revision of the guidance MDCG 2019-07 on Article 15 of...

The Medical Device Coordination Group (MDCG) has made several additions throughout the MDCG 2019-7 guidance, including on the qualifications, professional (...)

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Happy New Year 2024

All the best for 2024! In this time of regulatory change, all of our teams would like to thank you (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Mar 05 - 06, 2024 Training | Virtual Classroom

Technical Documentation per Medical Devices Regulation (EU) 2017/745

Mar 14, 2024 COVARTIM | Brussels, Belgium

MedTech Meetup 2024

Mar 25 - 28, 2024 Training | Virtual

Medical Device Electrical Safety