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.

structure
70
84
10
10
10
10
10
10
10

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
310
people dedicated to certification
+41%
growth in personnel since 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.

01 device 9
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.

02 Conference 6
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…

MDCG 2023-1: Guidance on the health institution exemption under Article 5(5)...

The Medical Device Coordination Group (MDCG) has published the guidance MDCG 2023-1 which aims to support a harmonised application of (...)

Learn more

European Commission Newsletter on medical devices | December 2022

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

Learn more

Dr. Duncan McPherson appointed to WHO expert group on medical devices

Dr Duncan McPherson, who recently joined LNE-GMED UK as internal clinician, has been appointed as a member of the first-ever (...)

Learn more

Proposal for a regulation amending Regulations (EU) 2017/745 and (EU) 2017/746

The European Commission has adopted a proposal for a regulation amending the transitional provisions of Regulations (EU) 2017/745 and (EU) (...)

Learn more

Best wishes 2023

3, 2, 1… Happy New Year! From Paris to Washington D.C. through London, the GMED group teams line up today (...)

Learn more

MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to...

The Medical Device Coordination Group (MDCG) has published the MDCG 2022-21 guidance on the Periodic Safety Update Report (PSUR). In (...)

Learn more

Version 2 – Manual on borderline and classification for medical devices...

The working group on “Borderline and Classification” has just made available on the European Commission website the 2nd version of (...)

Learn more

Communication on the draft amendment for the postponement of the EU...

During the Council of the European Union meeting on December 9, 2022 devoted to the Employment, Social Policy, Health and (...)

Learn more

News

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

Visit the Knowledge Center

Upcoming Events

Feb 07 - 08, 2023 Q1 Productions | San Diego, CA

16th annual IVD Clinical & Regulatory Affairs Conference

Feb 16 - 17, 2023 Training | Virtual Classroom

Post Market Surveillance and Vigilance New Requirements under the (EU) MDR/IVDR

Mar 22 - 23, 2023 Q1 Productions | Brussels, Belgium

5th EU IVD Clinical & Regulatory Conference