Early Design Controls and Documentation for Medical Devices

About this course:

Though safety and efficacy are of utmost importance to the medical device development process, medical device companies must also “show their work” and demonstrate that a product came from a systematic design process. While a mature medical device company will have an established quality system to support the entire development of new devices, start-ups often must build their quality structure as they go. Every designer working at an early-stage medical device company needs to be able to implement certain design control processes and document their own work. This course emphasizes the critical nature of having well defined inputs and outputs, and provides practical experience in performing different documentation tasks. Students will understand how these elements critically influence successive design stages including Validation and Transfer to Manufacturing.