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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.

Latest News

CE Marking of Medical Devices: Elements to be provided during the Evaluation of the Technical Documentation

  • October 10 - 2017

In the context of EC type and EC Design examinations, LNE / G-MED provides Medical Device Manufacturers with a list of the elements to be supplied for the CE marking of their medical devices. The list shall specify the content of the Dossiers to be submitted to the Notified Body as part of their...

Free webinar - IVD European Regulation: how QMS requirements interacts with ISO 13485:2016

  • September 12 - 2017

Join us on Wednesday, September 27th, 2017, 2:00 pm Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on IVD European Regulation: how QMS requirements interacts with ISO 13485:2016. Register Now!

Medical Device Usability: Highlights of European Regulations and Standards

  • August 15 - 2017

On November 1999, the Institute Of Medicine published “To Err Is Human”, a report analyzing the mortality of people in hospitals in the United State (up to 98000 deaths) as a result of medical errors, laying out strategies to “reduce preventable medical errors”. As per this report, medical errors,...

Free Webinar - Usability for Medical Devices: Highlights of the European Regulations and Standards

  • August 11 - 2017

Join us on Wednesday, August 30th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Usability for Medical Devices: Highlights of the European Regulations and Standards Register Now!

Biocompatibility: How to demonstrate the control of the biological risk according to the NF EN ISO 10993-1 (2010) standard ?

  • July 20 - 2017

Join us on Wednesday, July 26th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Biocompatibility: How to demonstrate the control of the biological risk according to the NF EN ISO 10993-1 (2010) standard ? Register Now!

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