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
350
people dedicated to certification
+66%
growth in personnel in 5 years
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…

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

The Commission Implementing Decisions (EU) 2024/2631 and (EU) 2024/2625 have been published in the Official Journal of the European Union (...)

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GMED Highlights: launch our new monthly format

We are delighted to announce the launch of our new format, GMED Highlights. Every month, GMED Highlights brings you a (...)

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Creation of subsidiary GMED Asia: GMED continues to expand internationally

GMED, a subsidiary of the LNE group, is expanding its certification business with the creation of GMED Asia, based in (...)

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UKCA, MDSAP, UKAS and now COFRAC accredited services all managed locally...

Based in London, LNE-GMED-UK has been officially designated as a critical location for both GMED’s COFRAC accreditation and MDSAP Auditing (...)

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Update of the MDSAP AU P0002 document – Audit Approach

An updated version (version 009) of the MDSAP Audit Approach is now available. The following changes have been made: Update/removal (...)

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AI Act: publication in the OJEU

On Friday July 12th, 2024, Regulation (UE) 2024/1689 was published in the Official Journal of the European Union (OJEU). Better (...)

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1st revision of the MDCG 2021-5 guidance on standardisation for medical...

This document aims to provide guidance relating to the medical devices sector standards, in support of the requirements laid down (...)

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Regulation (EU) 2024/1860: Extension of the IVDR transitional period and other...

The Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) has been published in the Official Journal (...)

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News

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

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Upcoming Events

Oct 17 - 18, 2024 TEAM-PRRC | Malaga, Spain

TEAM-PRRC THIRD ANNUAL SUMMIT

Oct 22 - 23, 2024 Training | Virtual Classroom

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

Oct 23 - 24, 2024 Irish Medtech | Galway, Irland

Global Access 2024