What the course covers

1. Introduction
2. Requirements, guidance and definitions
3. The clinical evaluation plan
4. State of the art
5. Identification and appraisal of clinical data
6. Analysis of clinical data
7. Clinical equivalence
8. Legacy devices and sufficient clinical evidence
9. Clinical evaluation of medical device software
10. Article 61(10): the route without clinical data
11. The Clinical Evaluation Report
12. Clinical investigation
13. Clinical evaluation and post-market clinical follow-up