- Cinical Affairs staff
- Regulatory Affairs professionals
- Medical Writer
- Quality system and quality assurance personnel
- Technical and Medical Writers
- CROs
- Those who conduct clinical evaluations/investigations/post-market follow-up studies
- Professionals moving from pharmaceuticals to medical devices
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Printable Version
At the end of the training path, you will be able to
Appropriately address the requirements for clinical evaluation for all classes of devices, regardless of risk classification
Know how to establish measurable endpoints for clinical claims and guide a straight-forward literature search and source additional data
Know how to avoid common pitfalls when addressing the benefit/risk profile of your medical device and be compliant with related requirements
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