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…

LNE-GMED UK designated for in vitro diagnostic medical devices under UK...

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

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GMED at RAPS Euro Convergence 2024

Join us in Berlin from May 6 to 8 for RAPS Euro Convergence 2024, the must-attend event for medical device (...)

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How to change your Approved Body to LNE-GMED UK in 8...

Within the constantly changing regulatory framework, more and more companies are requesting the transfer of their certificates to an Approved (...)

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LNE-GMED UK accredited for IVDs under ISO/IEC 17021-1:2015 standard

LNE-GMED UK, GMED subsidiary of the LNE group, has extended its accreditation by UKAS under ISO/IEC 17021-1:2015 for quality management (...)

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Guidance MDCG 2024-3 on content of the Clinical Investigation Plan for...

The Medical Device Coordination Group (MDCG) has published the MDCG 2024-3 guide regarding the content of the clinical investigation plan (...)

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Periodic safety update reports for devices: requirements and feedback

The Periodic Safety Update Report or PSUR for devices is a new requirement that stems from Article 86 of the (...)

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Update of the list of harmonised standards under Regulations (EU) 2017/745...

The Commission Implementing Decisions (EU) 2024/815 and (EU) 2024/817 have been published in the Official Journal of the European Union (...)

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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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News

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

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Upcoming Events

May 06 - 08, 2024 RAPS | Berlin, Germany

Euro RAPS Convergence 2024

May 15 - 18, 2024 IHPBA | Cap Town, South Africa

16th IHPBA 2024 World Congress

May 22 - 24, 2024 MedTech Europe | Vienna, Austria

The MedTech Forum 2024