Module 14 2022

21/03/2022

Statistical Techniques in D&D Toolkit

• Stats techniques that simplify formal verification testing, expedite product development and reduce costs • E.g. Demonstration by Analysis, Worst-Case Testing, Design Review/Inspection, and Digital/Binary Demonstration • Cases that cannot be verified by such method can be evaluated with risk categorization appoach • Triage requirements allowing reduced sample sizes for lower risk items (safety vs. non-safety-related)

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

7

Clinical investigations of medical devices

The Organisation for Professionals in Regulatory Affairs

Statistical Considerations in Medical Device Clinical Investigations

8

4