https://lne-gmed.com
Medical Device Certification
GMED, a leading notified body, is the international partner for conformity assessment, certification, and training in medical devices.
Medical Device Certification Home En Fr Careers Contact Certificate Repository Join Our Newsletter Search for:Search Button Menu Services CertificationWhatever the size of your company, wherever you are based, and whatever the category of your medical devices, we make it our mission to support you throughout your certification process. CE Marking QMS Certification MDSAP Program FAQ TrainingThe GMED North America Training Center delivers to you its expertise to enhance and develop your skills. Training Catalog Request a Training Focus on Medical DevicesTechnical and regulatory information in key medical device fields. Medical Devices Electromedical Devices In Vitro Diagnostic Medical Devices Company CompanyGMED’s level of excellence and standards have made it an internationally recognized name in the field of medical device certification. About GMED Choose GMED Leadership Recognition and Accreditation Governance Role of Notified Bodies Knowledge Center Events Search open Certification Application Search Submit All Categories All Categories Pages Trainings Knowledge Center Events Careers 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. Scroll down 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 Choose GMED 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. CE Marking QMS Certification MDSAP Program 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. Course Catalog Request a training LNE Service Medical Device Testing Testing your medical devices to ensure conformity with applicable technical standards LEARN MORE Service Focus on Medical Devices Delivering technical and regulatory information in key medical device fields: Medical Devices Electromedical Devices In Vitro Diagnostic Medical Devices Working at GMED Unleash your potential, leverage your expertise and be part of a dynamic, flexible team at a human-centered company. Browse our Job Openings and Mission News View all our technical, regulatory and normative information including guides, webinars, news… Visit the Knowledge Center 2026 US Medical Device & Diagnostic Clinical Evidence Conference Tuesday March 3rd 2026 US Medical Device & Diagnostic Clinical Evidence Conference GMED at the 2026 US Medical Device & Diagnostic Clinical Evidence Conference 24–26 March 2026 | Boston, MA GMED is (...) Learn more The 23rd China International In Vitro Diagnostic Expo (CACLP) Tuesday March 3rd The 23rd China International In Vitro Diagnostic Expo (CACLP) We are pleased to announce that Frederic Rocher, General Manager at GMED Asia, will be present at the CACLP 2026, (...) Learn more China International Medical Equipment Fair 2026 (CMEF) Tuesday March 3rd China International Medical Equipment Fair 2026 (CMEF) We are pleased to share that Frederic Rocher, General Manager at GMED Asia, will be attending CMEF 2026, one of (...) Learn more GMED at the Global Regulatory Strategy Conference in Baltimore Tuesday February 17th GMED at the Global Regulatory Strategy Conference in Baltimore GMED is pleased to announce that Shahriar Sharifi and Florianne Torset-Bonfillou will be representing our organization at the forthcoming Global (...) Learn more New EU Harmonized Standards for Sterilization Processes and IVD Labelling Requirements Tuesday February 3rd New EU Harmonized Standards for Sterilization Processes and IVD Labelling Requirements The European Commission has just published Implementing Decision (EU) 2026/197, marking a step forward for the regulatory framework governing in (...) Learn more New Harmonized Standards Added Under EU MDR Monday February 2nd New Harmonized Standards Added Under EU MDR On 30 January 2026, the European Commission published Implementing Decision (EU) 2026/193, updating the list of harmonized standards supporting the (...) Learn more Safety and performance of non-active implants: how to meet the preclinical requirements of Regulation (EU) 2017/745? Thursday January 29th Safety and performance of non-active implants: how to meet the preclinical... Demonstrating the safety and performance of non-active surgical implants relies on rigorous preclinical data, guided by constantly evolving standards and (...) Learn more 2026: Innovating Together for a Safer World Monday January 5th 2026: Innovating Together for a Safer World As we step into this new year, our teams in Paris, Washington, D.C., and Hong Kong extend their best wishes (...) Learn more Visit the Knowledge Center News View all our technical, regulatory and normative information including guides, webinars, news… Visit the Knowledge Center Upcoming Events More Events Mar 10, 2026 Training | Virtual Classroom Post Market Surveillance and Vigilance REGISTER NOW Mar 10 - 11, 2026 Training | Virtual Classroom Technical Documentation per In Vitro Diagnostic Devices Regulation (EU) 2017/746 REGISTER NOW Mar 21 - 23, 2026 CACLP | Xiamen, China The 23rd China International In Vitro Diagnostic Expo Learn more Upcoming Events More Events Mar 10, 2026 Training | Virtual Classroom Post Market Surveillance and Vigilance Learn more Mar 10 - 11, 2026 Training | Virtual Classroom Technical Documentation per In Vitro Diagnostic Devices Regulation (EU) 2017/746 Learn more Mar 21 - 23, 2026 CACLP | Xiamen, China The 23rd China International In Vitro Diagnostic Expo Learn more Newsletter Keep up with medical device industry news Subscribe Certification CE Marking QMS Certification MDSAP Program FAQ Services Training Medical Device Testing Company About Us Choose GMED Leadership Governance Recognition and Accreditation Role of Notified Bodies Careers Contact Further Information GMED Connect Knowledge Center Events Focus on Medical Devices Certificate Repository fostering a culture of partnership to advance global healthcare 1 rue Gaston Boissier, Paris, France 2600 Tower Oaks Blvd, Rockville, Maryland, USA 1 Wing Ming Street, Lai Chi Kok, Kowloon, Hong Kong 19 D rue de la Télématique, Saint-Etienne, France +1 (301)-495-0477 Follow us on Facebook Youtube Personal Data Protection Policy Legal mentions | Sitemap Manage Cookie Consent GMED uses cookies in order to personalize your experience for optimal performance. 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