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.