Consulting: Clinical Evaluation
The Directive 2007/47/EC clarified the need for clinical evaluations for all medical devices. The establishment of the amended guideline (MEDDEV), the harmonized standard concerning "Clinical investigation of medical devices for human subject" and the authorization procedures which have been established for clinical trials represent additional sources of uncertainty in the industry.
MDSS gives advice concerning the clinical evaluation of your medical device with the required intensiveness. In addition, we offer comprehensive regulatory consultation with the implementation of clinical trials.
If you would like to receive further information about this service please feel free to contact MDSS Consultancy via our contact form. We are looking forward to hearing from you.