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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 and Online training courses.

Upcoming Courses: Transition to the new ISO 9001:2015 and ISO 13485:2016 standards

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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

Clinical evidence requirements of In vitro Diagnostic Devices in the future EU IVD Regulation

  • July 18 - 2016

In September 26th 2012, the European Commission proposed a draft for an in vitro diagnostic Regulation in order to overcome flaws and divergences in interpretation of the current IVD Directive 98/79/EC and to further strengthen patient safety. Since then this draft have been amended by the...

Moving from ISO 9001:2008 to ISO 9001:2015, Evolution of the Standard

  • June 20 - 2016

Since its first publication in 1987, ISO 9001 has been revised several times to remain relevant and in line with the market needs of businesses. A new revision of the standard was launched in September 2015; replacing the latest version published in 2008. With over 1.2 million companies...

FREE Webinar: Clinical Evaluation Requirements for In Vitro Diagnostic Devices (IVDs) in the upcoming IVD Regulation

  • June 07 - 2016

Join us on Wednesday, June 29th, 2016, at 2 pm Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on Clinical Evaluation Requirements for In Vitro Diagnostic Devices (IVDs) in the upcoming IVD Regulation. Register now!

The new Medical Device Regulation is moving forward

  • May 27 - 2016

The Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement on the drafted Medical Device and IVD Regulations.

Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals

  • May 16 - 2016

There is a growing need in the current global economy to outsource with no foreseeable turning back. Medical Device and In Vitro Diagnostic Manufacturers in the United States are in constant need to tap in new markets (Europe with CE marking, Canada with CMDCAS and soon Japan, Brazil and Australia...

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