Full course coming soon

Building Evidence Plans for Regulated Health Technology

7 chapters · 29 lessons

1. 1. From Product Claims to Evidence Requirements

   4 lessons

   Map intended use statements to the types and rigor of evidence regulators and clinicians expect.

2. 2. Designing Technical and Clinical Validation Studies

   5 lessons

   Choose study designs that generate credible performance data for your product category and setting.

3. 3. Population Representativeness and Subgroup Analysis

   4 lessons

   Ensure validation datasets and study cohorts reflect real-world diversity and clinical variability.

4. 4. Performance Metrics and Acceptable Thresholds

   4 lessons

   Select metrics that reflect clinical utility and communicate risk in terms stakeholders understand.

5. 5. Post-Market Surveillance and Performance Monitoring

   4 lessons

   Build systems to detect performance drift, adverse events, and usage patterns after deployment.

6. 6. Documentation and Regulatory Submission Packages

   4 lessons

   Compile evidence into structured technical files, 510(k)s, or CE mark submissions.

7. 7. Special Considerations for Adaptive and AI Systems

   4 lessons

   Address unique evidence challenges when algorithms learn, update, or interact with users.