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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

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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