Clinical Evaluations and Clinical Studies

The EU Directive 2007/47/EC emphasizes the need for clinical data and clinical evaluation for medical devices intended to be CE marked. Guideline MEDDEV 2.7/1 revision 4 has further raised the compliance bar.

We can help you with:

  • Clinical evaluation reports
  • Literature reviews
  • Appraisal of clinical data
  • Analysis of clinical data
  • Reviewing clinical evaluation reports
  • Training

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