MEDICAL DEVICE PROTOTYPE DEVELOPMENT.

Catalog description

Students in this course are grouped in small teams to practice the design and development of a medical device that strictly adheres to the needed controls for regulatory affair approval of the product. The teams will be provided with a typical medical device manufacturer's standard operating procedure (SOP) and will be asked to apply that to their design. The teams demonstrate their understanding and implementation of design input, history file documentation, verification, and validation.