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.


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.

years of experience
people dedicated to certification
growth in personnel in 2019


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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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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Medical Device Testing

Testing your medical devices to ensure conformity with applicable technical standards


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.

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

Factsheet of the European Commission of Class I medical devices under...

Are you a manufacturer of Class 1 medical devices? What you need to know about Regulation (EU) 2017/ 745 is (...)

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Publication of a new revision (rev. 4) of the MDCG 2018-1...

In the MDCG 2018-1 Rev. 4 Guidance, the definition of the basic UDI-DI has been revised by deleting the concept (...)

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Certification process for SARS-CoV-2 self-tests

In the context of the health crisis, the French and European authorities have authorized a derogation for the placing on (...)

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Clinical evaluation in the era of Regulation (EU) 2017/745

In few months, the European Directives 93/42/EEC concerning  medical devices and 90/385/EEC concerning active implantable medical devices will be repealed (...)

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MDCG Infographic “Is your software a medical device ?”

The European Commission has just published the infographic titled “Is your software a medical device?” This infographic outlines the main (...)

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Publication of a European Commission guide on the management of Legacy...

The European Commission has published a guide on the management of Legacy Devices in EUDAMED. Legacy devices are defined as (...)

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MDCG 2021-1: Guidance on harmonised administrative practices and alternative technical solutions...

The European Commission has just published the Guidance MDCG 2021-1. This document intends to describe harmonized administrative practices and alternative (...)

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GMED has certified its first medical devices under Regulation (EU) 2017/745

GMED is pleased to announce that its team has issued its first certificates under the European Medical Device Regulation. Since (...)

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

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Upcoming Events

May 10 - 11, 2021 Training | Virtual Classroom

Medical Device Electrical Safety (IEC 60601-1 3rd Edition)

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)

May 17, 2021 Training | Virtual Classroom

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

May 24 - 25, 2021 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745