MDI5008: Quality, Regulatory, and Operations Management

MDI 5008 is built on understanding and applying the Total Product Life Cycle (TPLC) and Product Development Stage Gate methodologies as they relate to the global quality and regulatory environment in which the medical device industry operates. This is a practicum-based course using authentic FDA and ISO requirements to prepare the real-world documents and reports that are associated with the development of medical devices through to commercialization (pre-market to post-market) and includes key Operations Management principles that translate to delivering the product to market. The framework of the course and materials studied focus on effectively navigating the regulatory labyrinth to bring new and novel medical devices to market.

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