BME 361Biomedical Product Design and Regulation

The course covers topics related to product design and regulatory processes as it pertains to biomedical devices. Various regulatory pathways will be covered and how these regulations influence design and development will be explored. Students will gain an understanding of the engineering processes necessary to ensure safety and efficacy during commercialization of novel biomedical products by examining regulatory processes, design controls, risks assessments, non-clinical testing, design verification and validation strategies, and postmarket requirements.