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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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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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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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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

Release of 2 New Corrigenda Regulations (EU) 2017/745 and (EU) 2017/746

  • May 29 - 2019

On March 13th, 2019 the Council of the European Union released two corrigenda documents, pertaining to the Regulation (EU) 2017/745 on Medical Devices and the (EU) 2017/746 on In Vitro Diagnostics Medical Devices. In an effort to rectify mistakes and discrepancies within the new European...

EMA releases 1st guidance on new rules for certain Medical Devices; it is Article 117 intensive.

  • May 14 - 2019

    The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope...

Where are Notified Bodies with their application to the EU IVDR 2017/746?

  • February 11 - 2019

       A recent survey was conducted by Team-NB to determine how notified bodies were approaching the application process for designation under the new EU IVDR 2017/746. The survey report was closed on January 11th, 2019 and reveals that a total of 35 notified bodies responded,...

EU MD (2017/745) and IVD (2017/746) Regulations Pausing to reflect on a Year of Application for Notified Bodies

  • January 18 - 2019

November 26th , 2017 saw Notified Bodies able to engage with their designated Competent Authority (CA) to apply for a notification status under the EU MD (2017/745) and/or IVD (2017/746) regulations.

Implementation of the New Medical Device European Regulation (EU) 2017/745 in Non-European Union Member States

  • January 16 - 2019

      Since its publication, many articles have been published regarding the potential implications of the new European Medical Device Regulation (MDR) on the CE-marked medical devices within the European Union. However this change of regulation goes further than only the European...

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