This course covers current FDA regulatory compliance with respect to developing medical devices. Focus will be placed on relevant aspects of FDA regulation to Validation & Verification (V&V), risk analysis and the FDA’s supplemental guidelines. An ISO perspective is offered to compliment the FDA view. Among the topics to be discussed are: Context of V&V and risk analysis within the overall quality system and regulation; V&V and Risk analysis procedures; V&V methodologies; V&V strategies; types of risk analysis; risk mitigation; and methods to determine probability and severity for risk analysis.