Medical Device Design and Regulation
Taking a medical device from clinical need to market under design controls, risk management and regulation.
BME-400 Year 4 3 credits 12 lessons planned ▶ Video lessons coming soon
Offered by HSM University · Biomedical Engineering
Course content
- 1Identifying clinical needsComing
- 2Design inputs and requirementsComing
- 3Design controls and the design history fileComing
- 4Risk management (ISO 14971)Coming
- 5Usability and human factorsComing
- 6Verification and validationComing
- 7Software as a medical deviceComing
- 8FDA device classes, 510(k) and PMAComing
- 9Quality management systems (ISO 13485)Coming
- 10Clinical evaluation and trialsComing
- 11Intellectual property and commercializationComing
- 12Post-market surveillance and recallsComing
Requirements
Recommended background. You can start any course at any time.
Description
Taking a medical device from clinical need to market under design controls, risk management and regulation.
Part of the Engineering stream, typically taken in year 4.