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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

Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives

  • May 15 - 2017

The ISO 13485 standard represents a Quality Management System base for many regulatory schemes. With the recent publication of the new Medical Device and In Vitro Diagnostic Regulations, the regulatory framework surrounding Medical Devices evolves and re-enforces the control of external parties...

Free Webinar - Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives

  • May 08 - 2017

Join us on Wednesday, May 24th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives. Register Now!

The MDR and IVDR published today in the Official Journal of the European Union

  • May 05 - 2017

The Medical and In Vitro Diagnostic Medical Devices regulations (MDR and IVDR) have been published on May 5th, 2017 in the Official Journal.

The Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR): Changes and Impacts

  • April 18 - 2017

The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the...

The IMDRF publishes a new guideline on Adverse Event Reporting for Medical Devices

  • April 17 - 2017

Within the last few years, the Medical Device industry has witnessed a series of changes. The last one took place on April 5th, when the EU Parliament concluded years of tractions and discussions with the vote of the Medical Device and In Vitro Diagnostic Regulations.

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ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

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