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.

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

25
years of experience
+220
people dedicated to certification
+20%
growth in personnel in 2019
Service

Certification

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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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…

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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MDSAP Program: Principles, Implementation and Advantages

The Medical Device Single Audit Program (MDSAP) is an initiative started in 2012. This young program has been accepted by (...)

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Appointment of expert panels by the European Commission

The European Commission has just appointed expert panels in the field of medical devices and in vitro diagnostic medical devices (...)

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GMED Newsletter : Qualification and Classification of Medical Device Software under...

Last October, when our website was launched, you discovered our new Knowledge Center, centralizing our news, guides and webinars. Today, (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Apr 20, 2021 Training | Virtual Classroom

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

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 24 - 25, 2021 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745