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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, AIMD, IVD, MDSAP, ISO 13485, ISO 9001NF Mark for Medical and Health products, etc.

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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

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...

ISO 13485 standard for the medical device industry: Embrace the 2016 version!

  • March 29 - 2016

On March 1st, 2016, the latest revision of ISO 13485, the internationally recognized Quality Management Systems standard for the medical device industry was officially published. ISO 13485:2016 is now here and ready to take over ISO 13485: 2003.

FREE Webinar: Evolutions of ISO 9001:2015 and ISO 13485:2016 standards

  • March 17 - 2016

Join us Wednesday, April 20th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the Evolutions of ISO 9001:2015 and ISO 13485:2016 standards Register now!

MDSAP, Prepare for the transition

  • February 25 - 2016

In 2012, The International Medical Device Regulators Forum (IMDRF) recognized the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. It was at that point that the concept for the Medical Device Single Audit...

Training Announcement: Transition to ISO 13485:2016 and ISO 9001:2015 standards

  • February 17 - 2016

2 days training course designed and delivered by our expert dedicated to the Transition to the new ISO 9001:2015 and ISO 13485:2016 standards With over one million certified companies over the world, the international quality management systems standards ISO 9001 and ISO 13485 are among the...

Why Choose Us

  • Over a Century of Excellence

    LNE is France’s leading Notified Body and the only one with a role in developing standards. Companies, governments, and NGOs have trusted LNE and its expertise for over 100 years. As it carries on its original role as the metrology and standardization laboratory for France, LNE shares its expertise in standard development and R&D with standards organizations such as AFNOR, CEN, and NIST.

  • A Single-Source Provider to Serve You

    With wide range of certification services, we are committed to helping you understand the critical steps to consider and ensure your device complies with the regulatory requirements from an early stage:

    lne gmed arrow Give you the tools for maintaining compliance

    lne gmed arrow Test and Inspect at various stages of Production and Manufacture

    lne gmed arrow Provide Regulatory and Technical assistance.

    LNE/G-MED is a single-source provider of Voluntary and Regulatory certifications and offer complete certification package to save you the time and cost of multiple audits.

    Our full range of technical conformity services allows the convenience and efficiency of a US-based team of technical experts, auditors and program managers and makes us one of the leading European Notified Bodies in North America.

  • Highly-Qualified Experts and Professionals

    Notified Body Code of Conduct and Regulation 920/2013 place an increased emphasis on Notified Body certification staff and their credentials. LNE/GMED‘s long-standing hiring and training practices are serving you well.

    lne gmed arrow Our first consideration when sending auditors is their qualification and expertise with respect to your device and activities.

    lne gmed arrow Our team of Auditors is qualified both for CE marking and QMS assessment to combine your certification needs and reduce your costs.

    lne gmed arrow A dedicated Certification Project Manager very familiar with and available for your certification process and needs is allocated to you. Most of our CPMs are also qualified Lead Auditors and know the auditing and certification processes inside and out.

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