Course Offerings

Learn the principles, requirements, and expectations of Current Good Manufacturing Practices (CGMP) for medical device production. Topics covered include the regulatory definition of what constitutes a medical device, the divisions of the FDA responsible for medical device applications and compliance, and how the risk-based regulatory categorization of medical devices affects the scope of applicable CGMPs. Interactive exercises will guide students through the utilization of the FDA website to access regulatory and guidance information related to medical devices and to review past regulatory action taken by the FDA for failures in medical device compliance. Additional discussion and exercises will address the application of design control, verification, and validation principles to medical devices.