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Certification

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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Testing

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.

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Training

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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Library

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.

Our services

Latest News

Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers

  • February 14 - 2017

The certification audit is a though exercise and a major step for Medical Device Manufacturers looking to access a targeted market.  If you are looking to launch your company and your products or simply step into the world of the medical device industry, then be sure to thoughtfully plan and...

FREE Webinar: Ready for initial Certification Audit Common Pitfalls

  • February 02 - 2017

Join us on Wednesday, February 22nd at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the Initial Audits – Common Pitfalls. Register Now!  

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!  

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