- Clinical Affairs staff
- Regulatory affairs professionals
- Technical and Medical Writers
- Quality system and quality assurance personnel
- CROs
- Those who conduct clinical evaluations/investigations/post-market follow-up studies
- Professionals moving from pharmaceuticals to medical devices
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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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