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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

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!

Cyber security for medical devices: An overview of applicable regulations

  • July 20 - 2017

An ever increasing number of medical devices are being connected to hospital information networks via various types of connection (4G, Wi-Fi, Bluetooth and Ethernet). At the same time, more and more cases of issues associated with hacking, piracy and even theft of personal medical data are being...

Post-Market Surveillance (PMS) requirements under the new European Medical Device Regulations

  • June 20 - 2017

With the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR) on May the 25th, 2017, new requirements impacting Post Market Surveillance (PMS) have raised interrogations amongst Medical Device Manufacturers. While a continuous evaluation and improvement of the...

Post Market Surveillance requirements under the new European Medical Device Regulations

  • June 13 - 2017

Join us on Wednesday, June 28th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Post Market Surveillance requirements under the new European Medical Device Regulations. Register Now!

Application of the European MD and IVD Regulations: LNE / G-MED’s strategy in conducting the changes

  • June 05 - 2017

The European Regulations on Medical Devices including Active Implantable Medical Devices (AIMD), and In Vitro Diagnostic (IVD) Medical Devices have been officially published on May 5th, 2017. Both  entered into force on May the 25th, 2017.

Our Clients Say

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

Click here to Register