Clinical performance evaluations and clinical evidence reports

The EU Directive 98/79/EC requires clinical and analytical performance data for all in vitro diagnostic medical devices. The need for clinical data is further emphasized in the upcoming in vitro diagnostic medical devices regulation.

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