Clinical Evaluation Report
A Clinical Evaluation is the systematic process of continuously generating, collecting, analyzing and assessing the clinical data pertaining to a Medical Device (MD) and verifying its safety and performance. This information should be compiled in the Clinical Evaluation Report (CER), which will be part of the Technical Documentation.
How can DDR help?
- DDR will assist companies in preparing the CER by delivering a literature search and choosing those studies considered supportive.
- Furthermore, our team can search for an equivalent MD to explore its path to certification. In the event —that a Clinical Investigation is needed, DDR will ensure compliance with regulation.
- We may also compile all the documentation and elaborate the CER for the Technical Documentation to be assessed by a Notified Body.