Clinical performance evaluations and clinical evidence reports

Both current IVDD and the new IVDR 2017/746 require data for scientific validity, analytical performance and clinical performance to provide sufficient clinical evidence.  This is part of the CE marking process for in-vitro diagnostic medical devices to meet Essential Requirements in IVDD, as well as General Safety and Performance Requirements in IVDR.

We can help you with:

  • Clinical performance study protocol reviews
  • Clinical performance study protocol set up
  • Clinical evidence reports
  • Literature reviews
  • Reviewing clinical evidence reports
  • Training

Contact me for further information
Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail