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.

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 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.

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…

Guide MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for...

The MDCG has published a guide concerning the qualification of ethylene oxide (EtO) which led to the update of the (...)

Learn more

“AI Act”: what requirements and deadlines for medical devices?

On July 12, 2024, Regulation (EU) 2024/1689 was published in the Official Journal of the European Union. This “Regulation on (...)

Learn more

GMED at MedFIT

GMED will be attending MedFIT from December 3 to 4 at Lille and from December 11 to 12 for online (...)

Learn more

Updated Draft Statutory Instrument for Post-Market Surveillance: Gap Analysis

A new draft statutory instrument for post-marketing surveillance has been published. Our team has conducted a detailed gap analysis to (...)

Learn more

European Commission Newsletter on medical devices | October 2024

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

Learn more

Article 16 of Regulation (EU) 2017/745 & 2017/746: Requirements for distributors...

Regulations (EU) 2017/745 & 2017/746 introduce “new” requirements for distributors and importers who carry out activities involving the repackaging, supply (...)

Learn more

Revision of the guidance MDCG 2021-25 on the application of the...

The guidance MDCG 2021-25 on the application of the MDR requirements to ‘legacy devices’ has been updated in order to (...)

Learn more

MDCG 2024-11 guidance on qualification of in vitro diagnostic medical devices

On October 8, 2024, the MDCG published a guidance that clarifies what products fall in the scope of Regulation (UE) 2017/746 (...)

Learn more

News

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

Visit the Knowledge Center

Upcoming Events

Dec 03 - 04, 2024 Eurasanté, Medicalps, Clubster NHL, Biovalley France | Lille, France

MedFIT 2024

Jan 28 - 30, 2025 Training | Virtual Classroom

European Medical Device Regulation (EU) 2017/745

Feb 04 - 05, 2025 Training | Virtual Classroom

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