A detailed guide into the medical device Clinical Evaluation and the subsequent Clinical Evaluation Report (CER) processes. It is a breakdown of the definition of Clinical Evaluation within the EU MDR and provides powerful knowledge to navigate through Clinical Evaluation and successfully write CERs and CEPs.
Chapters:
1. What is Clinical Evaluation?
2. About Systematic Literature Reviews
3. An overview of Clinical Evaluation Report sections (1 - 11)
4. Information required for a new device
5. FAQs
