Biological evaluation of Medical Devices

 

  • Based on the nature and the classification of your medical device, our consultants determine the most appropriate nonclinical testing plan needed for its biological evaluation to support CE certification
  • Our experts assist you during the in vivo and in vitro biocompatibility testings and assays, review study protocols and reports, write expert reports, audit your CROs, monitor your subcontracted studies and interact with notified bodies on the biological evaluation of your Medical Device