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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

EU Commission releases MDR/IVDR – Implementation Rolling Plan. All the Essential Details You Need to Know

  • June 20 - 2019

The European Union has constructed an excel document detailing essential information regarding the MDR/IVDR implementation rolling plan. The document is organized into two different sections: implementing acts and other actions/initiatives. This document is intended to coexist with the “MDR/IVDR...

The Outcome of IMDRF-15 Management Committee Meeting. What impactful decisions did they make?

  • June 19 - 2019

The International Medical Device Regulators Forum (IMDRF) held the fifteenth meeting of the Management Committee (MC) in Moscow, Russia on March 18th -21st, 2019. The MC consisted of regulatory leaders from around the world such as: Australia, Brazil, Canada, China, the European Union (EU), Japan,...

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,...

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