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.


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.

years of experience
people dedicated to certification
growth in personnel since 2019


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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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


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


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

Q&A on transitional provisions for products without an intended medical purpose...

The European Commission has published a Q&A on the transitional provisions applicable to products without an intended medical purpose covered (...)

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European Commission Newsletter on medical devices | September 2023

This newsletter from the European Commission aims to provide highlights and updates from the medical devices (MDs) and in vitro (...)

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Andrew Bailey, Product Reviewer for Orthopaedic Implants, LNE-GMED UK

We are pleased to announce the arrival of Andrew Bailey to our subsidiary LNE-GMED UK, in the position of Product (...)

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Keeping pace with our growth, we’re moving to a new office

As part of the GMED Group’s expansion, GMED North America is excited to announce that we have relocated our office (...)

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Clinical evaluation: the strategic path of Well Established Technologies (WET) for...

Demonstration of compliance with general safety and performance requirements must be based on clinical data providing sufficient clinical evidence. The (...)

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Our priority at GMED North America’s Training Center is to deliver...

We invite you to take a minute of your time to share your insights on the challenges you would like (...)

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Conditions and deadlines for placing ‘legacy devices’ and class III custom-made...

The European Commission published a flowchart allowing the manufacturers to determine whether their devices can benefit from the new transitional (...)

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RAPS Convergence 2023 | Oct. 3-5 – Montreal, QC

“RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of (...)

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

Visit the Knowledge Center

Upcoming Events

Oct 03 - 05, 2023 RAPS | Montreal, QC, Canada

RAPS Convergence 2023

Oct 19 - 20, 2023 Q1 Productions | Brussels, Belgium

5th Annual EU IVD Clinical & Regulatory Conference

Oct 30 - 31, 2023 Training | Virtual Classroom

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