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Webinar: How to certify medical devices in Europe - JAN & FEB 2024

EFOR is thrilled to launch their first (FREE!) webinar series for their US customers on how to certify medical devices in Europe. 

The application of Medical Device Regulation (MDR) 2017/745 has imposed more stringent requirements on medical device manufacturers seeking to sell and distribute their devices in Europe. 

Their three-part webinar series “CERTIFYING MEDICAL DEVICES IN EUROPE” seeks to address four elements of CE-mark submissions that are challenging for manufacturers:

  • Regulatory requirements of MDR 2017/745
  • Biocompatibility and toxicological evaluations
  • Usability requirements 
  • Clinical evaluations and post-market clinical follow-up

 

Each webinar will explore the requirements imposed by MDR 2017/745 and how manufacturers must demonstrate compliance with these requirements.

Each webinar will be followed by a question-and-answer session – so come prepared with all of your questions!

Join them in their Boston offices (space is limited) or online from 9:30am to 11:00am EST on:

  • January 18, 2024: Understanding the requirements of the new Medical Device Regulation
  • January 25, 2024: Understanding biocompatibility, toxicology and usability requirements of MDR 2017/745
  • February 1, 2024: Understanding the clinical evaluation requirements of MDR 2017/745

Interested ? Join their experts Yannick SPENNINCK, Technical Director North America, Iphigénie HUSSON, Technical Expert Regulatory Affairs, Eléonore MICHEL, Technical Expert and Manager in biological evaluations and toxicology, Jean-Charles DOMENGET, Technical Expert in Usability of medical devices, and Katharina HOEGL, Technical Expert and Manager in clinical evaluations. 

PLUS D'ACTUALITÉS

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