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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

Notification of changes: How, what and when to communicate with your Notified Body

  • March 22 - 2017

The Medical Device Industry has always been one of the most demanding when it comes to satisfying its stakeholders. Satisfying and embracing the needs of multiple actors (market evolution, patient safety, investors, regulators and supply chains) has obligated Legal Manufacturers of medical...

Final version of the EU Medical Device and In Vitro Diagnostic Regulations: Let the vote begin!

  • March 13 - 2017

The Council of the European Union announced the publication on Wednesday February 22nd, 2017 of the final draft version for the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Both texts, respectively 566 pages and 477 pages, have been long-awaited and are now...

Transition to ISO 13485:2016, 1 Day Course

  • March 07 - 2017

With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used. Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market...

FREE Webinar - Notification of changes: How, what and when to communicate with your Notified Body?

  • March 01 - 2017

Join us on Wednesday, March 29th at 2:00 pm EDT as LNE/G-MED North America Inc. will be hosting a free informative session on Notification of changes: How, what and when to communicate with your Notified Body? Register Now!  

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...

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