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.

Medical Device certification
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.

Medical Device certification training
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.

Medical Device certification careers

News

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

Article 117 of Regulation (EU) 2017/745: What you need to know...

Many medicinal products are designed for use with a medical device or part of a medical device. Given the wide (...)

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Version 4 of the Manual on borderline and classification for medical...

This reference document, developed by the Borderline and Classification Working Group (subgroup of the Medical Device Coordination Group), provides essential (...)

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Team-NB Best Practice Guidance V2 on IVDR Technical Documentation Submissions (Annex...

Team-NB has published the first revision of its Best Practice Guidance for the submission of technical documentation pursuant Annex II (...)

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1st revision of MDCG 2024-14 guidance on the Master UDI-DI solution...

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 (...)

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GMED recognized as a conformity assessment body in South Africa

We are proud to announce that GMED has been recognized by the South African Health Products Regulatory Authority (SAHPRA) as (...)

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GMED North America at RAPS Convergence 2025

From October 7-9, 2025, in Pittsburgh, we will be attending RAPS Convergence, a major event for regulatory professionals in the (...)

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9th Annual Medical Device Global Post-Market Surveillance Conference

Join us at the 9th Annual Medical Device Post-Market Surveillance Conference in Arlington, VA hosted by Q1 Productions where Chris (...)

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Artificial intelligence & healthcare: a strategic turning point for Europe

The European Commission has just published its final study on the deployment of AI in healthcare systems. This analysis highlights: (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Sep 29 - Oct 01 TOPRA | Berlin, Germany

TOPRA Symposium 2025

Sep 29 - Oct 02 Training | Virtual

Medical Device Electrical Safety

Oct 07 - 09, 2025 RAPS | Pittsburg, Pennsylvania

RAPS Convergence 2025