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…

Questions & Answers from the European Commission on the European Medical...

The European Commission has just published a document gathering questions and answers on the EMDN. In accordance with Article 26 (...)

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FAQ on the European Medical Device Nomenclature (EMDN)

The Medical Device Coordination Group (MDCG) has just published the MDCG 2021-12 FAQ on medical devices and in vitro diagnostic (...)

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English version of the European Medical Device Nomenclature (EMDN)

A public consultation was organized by the European Commission on the European Nomenclature of MDs and IVD MDs (EMDN) within (...)

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MDCG 2021-08 Guidance on Clinical Investigation Application and Notification Documents

Medical Devices Coordination Group (MDCG) has published a guidance on clinical investigation Application and Notification documents. The sponsor of a (...)

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European Commission factsheet for manufacturers of implantable medical devices

Are you a manufacturer of implantable medical devices? Everything you need to know about the implant card and the information (...)

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Introduction to the Regulation (EU) 2017/746

The Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices entered into force on May 26th, 2017 and we (...)

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Launch of the Unique Device Identification (UDI) Helpdesk

On May 17, 2021, the European Commission launched a new helpdesk to assist economic operators in the implementing the obligations (...)

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Harmonized European Standards under the European Regulations on MD and IVD...

On May 12, 2021, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) formally informed (...)

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News

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

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Upcoming Events

Jun 28 - 29, 2021 Training | Virtual Classroom

Risk Management Applied to Medical Devices (ISO 14971:2019)