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Join us for a complimentary webinar where we will discuss the new Medical Device Regulation 2017/745 that was published in May 2017.  This new regulation replaces the EU’s current Medical Device Directives (93/42/EEC and 90/385/EEC).

This webinar will be presented by our team of expert clinical affairs consultants who will provide an overview of the new requirements of Medical Device Regulation 2017/745 as well as of the MEDDEV 2.7/1 Rev. 4 regarding clinical evaluations.

Learn from industry expert, Sandra Bugler, M.Sc. who will provide insights into the conduction of a clinical evaluation report and learn about the:

  • Interpretation of new requirements
  • Structure of clinical evaluation reports
  • Challenges regarding equivalent devices
  • Clinical data for class III and implantable devices
  • Post-Market Clinical Follow-up

Sandra Bugler is the Managing Consultant for Clinical Affairs at PROSYSTEM GmbH with several years of professional experience in the field of clinical & regulatory affairs. Her professional focus is on clinical data and clinical evaluations as well as investigations. She is an expert in the implementation of new clinical requirements especially with regard to the MEDDEV 2.7/1 rev. 4 and the new Medical Device Regulation 2017/745. She holds a master’s degree in Biomedical Engineering Science.

For more Information and registration click here.



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