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.

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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 France, Europe and North America, and our proven methodology make GMED an international reference body.

25
years of experience
+220
people dedicated to certification
+20%
growth in personnel in 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.

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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.

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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 2022-12: Harmonization of administrative practices and alternative technical solutions prior...

The MDCG (Medical Device Coordination Group) has just published the MDCG 2022-12. This guidance is intended to enable Member States (...)

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Current position of LNE-GMED UK after first review of the consultation...

On 26th June 2022, the UK Government outlined the results on the consultation on the future regulation of medical devices (...)

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Regulation on medical devices: the news of the month of June...

This special July edition is dedicated to two publications from June and the EPSCO (Employment, Social Policy, Health and Consumer (...)

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Implementing Regulation (EU) 2022/1107 laying down common specifications for Class D...

In order to provide appropriate provisions regarding Class D in vitro diagnostic medical devices, the European Commission has adopted the (...)

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Summary of Safety and Clinical Performance (SSCP): 5 Challenges to be...

The Summary of Safety and Clinical Performance (SSCP) is a requirement under the Regulation (EU) 2017/745 for class III and (...)

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Implementing Regulations (EU) 2022/944 and (EU) 2022/945 laying down detailed rules...

In order to provide the necessary modalities as mentioned in Article 100 of the Regulation (EU) 2017/746 concerning the EU (...)

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MDCG 2022-10: Q&A on the interface between Regulation (EU) 536/2014 on...

This Q&A intends to clarify certain interfaces between both following regulations: the Regulation (EU) No 536/2014 on clinical trials for (...)

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MDCG 2022-9: Summary of Safety and Performance template under Regulation (EU)...

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary (...)

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News

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

Visit the Knowledge Center

Upcoming Events

Aug 30 - 31, 2022 Training | Virtual

Medical Device Electrical Safety (IEC 60601-1 3rd Edition)

IEC 60601-1 3rd Edition represents the benchmark for medical electrical equipment and compliance to the standard is a requirement in many countries including Europe (EN 60601-1:2006)

Sep 26 - 27, 2022 Training | Virtual Classroom

ISO 13485:2016 Requirements

Oct 10, 2022 Training | Virtual Classroom

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