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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

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...

ISO 13485:2016 - Ready For the Next Revolution? Time for ISO TC 210 WG1 to Draw Up the Results

  • October 30 - 2018

A survey was recently administered by ISO TC210 WG1 to obtain critical information to evaluate the experiences of key stakeholders such as, medical device manufacturers, subcontractors, suppliers, European Authorized Representatives, specialized consulting firms etc., during the ISO 13485:2016...

Free webinar - Stepping into an MDSAP audit

  • September 05 - 2018

Join us on Wednesday, September 26th, 2018, 2:00 Eastern Time as GMED North America Inc. will be hosting a free informative session on Stepping into an MDSAP audit. Register Now!

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