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.
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.
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 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.
News
View all our technical, regulatory and normative information including guides, webinars, news…
Upcoming Events
Medical Device Single Audit Program (MDSAP) for Manufacturers
Post Market Surveillance and Vigilance New Requirements under the (EU) MDR/IVDR
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)