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lne gmed notified body certification 01

Product Certification and Quality Management System (QMS) services. A complete certification package to save you the time and costs.

CE mark, Active Implantable Medicale Devices, In Vitro Diagnostics, Single Audit Program, ISO 13485, ISO 9001.

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One of Europe’s Largest Testing Facility. Offer a complete range of standardized tests or customize tests for characterization.

Electromagnetic Compatibility (EMC), Electrical Safety, CB Scheme, Charpy reference specimens.

LNE GMED Notified Body Training Courses 03

A Training Organization with customized courses. Public, online our at your site, our Experts use practical examples in a dynamic and interactive atmosphere.

Check our Training List: ISO 9001:2015 and ISO 13485:2016 Transition, Sterilization Process, Software Lifecycle Processes, etc.

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Get the latest news on EU directives, Quality Standards and other important Regulatory Developments, along with practical Guidance for Compliance.

News, Technical Guides, Newsletter and Webinars.

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Latest News

5 Questions to Jumpstart the Transition Process to the New MDR and IVDR

  • January 17 - 2017

Welcome to 2017. With the new year rolling in, here come new resolutions … or should we say new Regulations. In June 2016, political agreements on the medical device and in vitro diagnostics medical device regulations were released and we are expecting these two new European regulations to be...

RAPS 2017: Book a Meeting Today!

  • November 30 - 2016

Save the date! RAPS 2017 - September 9 to 12. LNE/G-MED NA will participate to RAPS 2017 Regulatory Convergence, at the Gaylord National Resort & Convention Center at National Harbor, MD. The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community....

FREE Webinar, MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)

  • January 04 - 2017

Join us on Wednesday, January 25th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER) Register Now!  

Summary of the 2016 changes

  • December 20 - 2016

2016 has brought its share of changes and announcements in the applicable regulations and standards. Many actors have already started to perform Gap analysis, build plan, and update their Quality Management System to implement or anticipate these changes. For our last newsletter of the year, we...

Training Announcement: Transition to ISO 13485:2016

  • December 15 - 2016

Training course designed and delivered by our expert dedicated to the Transition to the new ISO 13485:2016 Standard Pick one date: February 14th or February 15th. Location: Soka University of AmericaSmall Conference Center One University DriveAliso Viejo, CA 92656

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