Performance evaluation (IVD)

The IVDR provides detailed requirements on performance evaluation. To CE-mark an IVD medical device the manufacturer must justify the scientific validity, the analytical performance and the clinical performance of the device.

We can help you with:

  • Identify any gaps in performance data
  • Plan clinical performance studies
  • Perform literature reviews
  • Review performance evaluation documentation
  • Review / develop procedures for your QMS
  • Resolve non-conformities
  • Provide training

Contact me for further information
Cecilia Emanuelsson
Office +46 8 621 01 05 or send me an e-mail