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…

Publication in the OJEU of Decision (EU) 2025/1324 on expert panels...

Implementing Decision (EU) 2025/1324 has just been published in the Official Journal of the European Union (July 8, 2025). It (...)

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Publication in the OJEU of Implementing Regulation (EU) 2025/1234 on electronic...

The European Commission has just published Implementing Regulation (EU) 2025/1234, amending Regulation (EU) 2021/2226 on electronic instructions for use (eIFU). (...)

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Unannounced audit: surveillance activities and post-certification monitoring like any other?

  The entry into force and implementation of Regulations (EU) 2017/745 and 2017/746 were marked by the introduction of high (...)

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AIB 2025-1 & MDCG 2025-6 Guidance: Interplay between the MDR/IVDR and...

The Medical Device Coordination Group (MDCG) and the Artificial Intelligence Board (AIB) have jointly released this new guidance document, offering (...)

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Revision of the MDCG 2019-11 guidance on the qualification and classification...

The MDCG has published a revision of the MDCG 2019-11 guidance, providing updates on the qualification and classification of medical (...)

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MDCG 2025-5 Q&A on Performance Studies under Regulation (EU) 2017/746

The Medical Device Coordination Group (MDCG) has just released a Q&A document providing regulatory clarification on performance studies for in (...)

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MDSAP.Global: GMED listed as a recognized Auditing Organization

The new official platform mdsap.global, developed by the Regulatory Authority Council behind the MDSAP, is now live. It offers manufacturers (...)

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Biological evaluation of gas pathways in medical devices

The ISO 10993 series provides a framework for the biological evaluation of all medical devices (MDs) that come into direct (...)

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News

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

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Upcoming Events

Jul 22 - 24, 2025 Training | Virtual

Medical Device Electrical Safety

Jul 29 - 30, 2025 Training | Virtual Classroom

Post Market Surveillance and Vigilance

Sep 16 - 17, 2025 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745