Clinical evaluation / Clinical investigation

The clinical evaluation report is a major document of the technical file for a medical device. The clinical evaluation is undertaken to ensure that there is sufficient clinical evidence to demonstrate that the device is safe to use and has adequate performance. Clinical data are generally required and may be acquired through clinical investigations.

We can help you with:

  • Develop an over-all clinical strategy
  • Identify any gaps in clinical data
  • Perform clinical evaluations
  • Perform literature reviews
  • Review clinical 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