Both current MDD and the new MDR 2017/745 require clinical data and sufficient clinical evidence as a basis for a clinical evaluation. This is a significant part of the CE marking process for medical devices to meet Essential Requirements in MDD, as well as General Safety and Performance Requirements in MDR.
We can help you with:
Clinical evaluation reports
Appraisal of clinical data
Analysis of clinical data
Reviewing clinical evaluation reports
Contact me for further information Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail