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…

Do you market class I medical devices under the Directive, which...

According to Regulation (EU) 2023/607, you have to submit an application for certification to a notified body before the May (...)

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The leadership of LNE-GMED UK is evolving

Teresa Perry has held the position of Branch Director and Head of Approved Body at LNE-GMED UK since May 1st, (...)

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GMED at MedTech Forum 2024

Meet our team at The MedTech Forum in Vienna from May 22 to 24, Europe’s leading healthcare and medical technology (...)

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MDCG 2024-4 guidance on safety reporting in performance studies of in...

The recording and reporting to competent authorities of adverse events occurring during performance studies of in vitro diagnostic medical devices (...)

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1st revision of the MDCG 2022-9 guidance on the template for...

Published by the Medical Device Coordination Group (MDCG), the MDCG 2022-9 guidance proposes a template to follow the Summary of (...)

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LNE-GMED UK full designation scope under UK Medical Devices Regulations 2002

LNE-GMED UK (AB 8521), a GMED subsidiary of the LNE Group, has now completed its designation scope under UK Medical (...)

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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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News

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

Visit the Knowledge Center

Upcoming Events

May 21 - 22, 2024 Q1 Productions | Chicago, IL

Q1 Productions: 14th Annual Medical Device & Diagnostic Labeling Conference

May 21 - 22, 2024 Q1 Productions | Chicago, IL

Q1 Productions: 17th IVD Clinical & Regulatory Affairs Conference

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

The MedTech Forum 2024