Medical Device Life-Cycle Management

A required course in the Medical Device Development and an elective course in the Regulatory Affairs & Compliance for Medical Devices and Regulatory Affairs & Compliance for Pharmaceuticals Certificate Programs.

From concept through development to approval, the Medical Device Life Cycle integrates design, development, validation, and commercialization. Further your understanding of the phases, requirements, and deliverables of the Device Life Cycle in order to manage projects and multifunctional teams. Topics covered include Product Development Process, Customer Requirements, Proof of Concept, Design Control, Design Verification and Validation, Design Transfer, Product Launch, Risk Management, regulatory strategy, intellectual property management, project management, start-up company experiences, and time to market.

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