Learn to apply design control to ensure safe, effective medical devices that meet FDA and ISO standards.
The successful development of medical devices requires that the design be controlled to ensure product safety and that the device can fulfill its intended use. This course provides a practical understanding of the engineering value of design control throughout the product lifecycle as it pertains to product quality. You'll learn to use the nine elements of design control to make design objectives clearer, products more testable, and to better satisfy customer requirements, thereby shortening the path to product and business success. The course highlights the practical implementation of the design history file, reviews and records, transfer planning, requirements engineering and project planning. You will also learn topics related to design verification and validation testing, such as process validation, biocompatibility, shelf-life, sterilization and packaging validation.
Students are expected to read the FDA Guidance on Design Control prior to the first class session.
Approved for 15 RAC recertification credits
