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…

2026: Innovating Together for a Safer World

As we step into this new year, our teams in Paris, Washington, D.C., and Hong Kong extend their best wishes (...)

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MDCG 2025-10: Guidance on post-market surveillance of medical devices and in...

The Medical Device Coordination Group (MDCG) has released its new guidance: “Post-Market Surveillance of Medical Devices and In Vitro Diagnostic (...)

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Implementing Regulation (EU) 2025/2526: Correction and Designation of EU Reference Laboratories...

The Commission Implementing Regulation (EU) 2025/2526, published on 17 December 2025, amends Regulation (EU) 2023/2713 to correct the designation of (...)

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MDCG 2025-7 Rev. 1: Implementation Timeline for Master UDI-DI for Contact...

The Revision 1 of MDCG 2025-7, published in December 2025, clarifies the key dates for implementing Master UDI-DI for contact (...)

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New Guidance MDCG 2025-9: Accelerating Access to Breakthrough Medical Devices in...

The Medical Device Coordination Group (MDCG) has published its 2025-9 guidance on Breakthrough Devices (BtX) under the Regulations (EU) 2017/745 (...)

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EUDAMED: 1st four fully functional modules

The European Commission has officially declared that 4 modules within the European Database on Medical Devices (EUDAMED) are now fully (...)

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GMED at MedFIT

GMED will be attending MedFIT in Strasbourg on December 2nd and 3rd, and virtually on December 8th! MedFIT is a (...)

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New Harmonized Standards for Medical Devices

On October 17, 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, updating harmonized standards for: Surgical clothing and drapes (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Jan 22, 2026 MLV & Akra Team | Webinar

2026 Regulatory Roadmap: Key MDR & IVDR Compliance Priorities

Jan 27 - 28, 2026 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745

Feb 10 - 11, 2026 Training | Virtual Classroom

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