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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

RAPS 2017: Book a Meeting Today!

  • November 30 - 2016

Save the date! RAPS 2017 - September 9 /12, 2017. 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....

Developing the right MRI safety assessment strategy: a major challenge for manufacturers of medical devices

  • October 18 - 2016

Medical devices manufacturers are regularly asked about the safety of their products when introduced into an MRI scanner (Magnetic Resonance Imaging). These questions usually come from competent authorities, notified bodies or medical teams. This is the subject of a regulatory strengthening and...

Clinical Evaluation of the Medical Devices – Key Changes in MEDDEV 2.7.1 Rev 4

  • October 06 - 2016

In June 2016, the new version (Rev.4) of MEDDEV 2.7.1 European guidance on the clinical evaluation of medical devices (MD) was published. It does not revolutionize the clinical evaluation approach but significantly increases the demands on the content of the file. The new guidance is longer and...

The New EU Regulation for Medical Devices at the OCRA forum

  • September 29 - 2016

Orange County Regulatory Affairs Discussion Group (OCRA) is inviting QA/RA management as well as key decision makers (CEO, CFO, and Internal Counsel) to discuss the business and financial implications of meeting the new regulations and engage with both seasoned Industry and Notified Body...

FREE Webinar, Embedded Software in Medical Device: Common Regulatory and Quality pitfalls

  • September 13 - 2016

Join us on Wednesday, September 28th at 2:00 PM Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on Embedded Software in Medical Device : Common Regulatory and Quality pitfalls. Register Now!  

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