Bouncing back on the path through NB’s question rounds – challenges and lessons learned during certification of clinical evaluation (class IIb and III)

About this session

Case study.

- Literature search – what literature source is relevant for my MD?
- Exploring how to align acceptance criteria for safety and performance with State of the art
- Is the clinical evidence sufficient for the entire dimensional range of my medical device?

Speaker

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  Renate Cizkova

  Head of Clinical Department · ELLA-CS

  Speaker