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