Curriculum
- 5 Sections
- 23 Lessons
- 1 Day
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- Foundations of Clinical Evaluation4
- Regulatory Guidance & Industry Expectations4
- Clinical Data Sources & Evaluation Pathways5
- Building & Maintaining a Robust CER6
- 4.1Structure of a Clinical Evaluation Report
- 4.2Critical appraisal of literature (exercise: scoring study quality)
- 4.3Gap analysis workshop: Identify missing evidence for a sample device
- 4.4Mock Notified Body Q&A on a CER submission
- 4.5Iterative Updates, Living CER, Clinical Evaluation Plan (CEP)
- 4.6Summary of Safety and Clinical Performance (SSCP)
- Forward-Looking Strategies & Wrap-Up4