Course Outlines
- Scope of the Law and Assessment, Medical Device Definitions, & The State of the Art.
- Identifying Devices, Combination Products, & Borderline Devices.
- Classification, Rules for Classification, & Guidance.
- Subcontractors, & Device Specification for Technical File.
- Essential Principles, Checklist, Verification and Validation, & Evidence Required.
- Risk Analysis, Relation to ISO 14971, Hazard Analysis, & Risk Analysis.
- Clinical Evaluation, Clinical, Evaluation Plan, Equivalence, & Essential Principles Met.
- Literature review, Clinical Evaluation Report, Labelling and instructions for use, & Design and Manufacturing.
- Declaration of Conformity, Post-Market Surveillance, & Post-Market Clinical Follow-Up.
- Periodic Safety Update Report, Summary of Safety and Clinical Performance, & Vigilance.
