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…

List of harmonized standards under Regulation (UE) 2017/745

For your information the European Commission has just published the implementing decision (UE) 2022/757 amending the list of harmonized European (...)

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List of harmonized standards under Regulation (EU) 2017/746

The European Commission has just published the implementing decision (EU) 2022/729 amending the list of harmonized European standards under Regulation (...)

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Guidance MDCG 2022-6 on significant changes regarding the transitional provision under...

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-6 which aim to provide clarification on the (...)

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Guidance MDCG 2022-5 on borderline between medical devices and medicinal products...

The MDCG (Medical Device Coordination Group) has just published the Guidance MDCG 2022-5 which aims to establish the demarcation between (...)

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UKCA marking: Key steps to consider

The United Kingdom left the European Union single market on 31st December 2020. As a consequence, the United Kingdom Conformity (...)

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Newsletter on Medical Devices | European Commission – April 2022

This newsletter from the European Commission aims to provide highlights and updates from the medical devices sector. In this new (...)

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Revision of Guide MDCG 2019-9 Rev.1 on the summary of safety...

The Medical Device Coordination Group (MDCG) has just published the updated Guide MDCG 2019-9 Rev.1. This March 2022 revision provides (...)

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Medical Devices Clinical Evaluation – Summary of Safety and Clinical Performance...

It is the manufacturer’s responsibility to specify and justify the level of clinical evidence necessary to demonstrate conformity with the (...)

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News

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

Visit the Knowledge Center

Upcoming Events

May 24, 2022 Training | Virtual Classroom

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

Jul 05 - 06, 2022 Training | TBD

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)

Jul 11, 2022 Training | Virtual Classroom

The Clinical Evaluation Requirements (CER) under the EU MDR 2017/745