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BSI White Paper on Generating Clinical Evaluation Reports

Blog focus BSI’s 2nd in a series of White Papers for Medical Device & IVD industries, on Generating clinical evaluation reports

White Paper on Generating clinical evaluation reports

This white paper is on “Generating clinical evaluation reports – A guide to effectively analysing medical device safety and performance” and is focused on “…guidance on how to satisfy important regulatory requirements e.g. the concept of equivalence and post-market clinical follow-up (PMCF).”  It is written by Dr Hassan Achakri, PhD, Director, International Clinical Affairs, Zimmer GmbH; Peter Fennema, Director, AMR Advanced Medical Research; and Dr Itoro Udofia, PhD, Orthopaedic & Dental Team Leader, BSI .

I have the distinct pleasure and honor of assisting BSI review this white paper as a member of the BSI Medical Devices White Paper Advisory Panel for this series of white papers.

White Paper Series and Future Topics to Come

BSI says of this series that “Throughout the year, we are going to be producing a series of medical devices white papers. These will keep you up to date with regulations, developments and help you prepare for changes within your industry.”

The additional white papers in the series will be on:

  • The digital patient
  • What medical device manufactures need to know about FDA’s Unique Device Identification Final Rule
  • Post-market surveillance
  • Usability engineering

You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). 

If you need help with your EU CE Mark Medical Device Directive or IVD Directive Technical Files or Design Dossiers, email Leo Eisner directly at Leo at EisnerSafety dot com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).