M	T	W	Th	F	Sa	Su
09/13: 5:45 pm 8:45 pm OSS 329 09/20: 5:45 pm 8:45 pm In Person 09/27 - 10/18: 5:45 pm 8:45 pm OSS 329 10/25 - 11/01: 5:45 pm 8:45 pm In Person 11/08: 5:45 pm 8:45 pm OSS 329 11/15 - 11/29: 5:45 pm 8:45 pm In Person 12/06 - 12/13: 5:45 pm 8:45 pm OSS 329

Subject: Engr Tech Leadrshp (Grad) (ETLS)

CRN: 40580

CoFlex:In Person&Online Sync | Lecture

St Paul: O'Shaughnessy Science Hall 329

St Paul: In Person

Roy Martin, Kimberly Anderson

Pre-clinical testing is utilized to evaluate the safety and potential efficacy of promising medical technologies prior to evaluation and use in human beings. This testing information is required by regulatory agencies around the world. The studies also provide extremely valuable and cost effective product development opportunities for medical product sponsors. The tests are defined by guidance documents, international standards and the formal product risk assessment. Coordination of the multifunctional team that acquires and also utilizes this data can greatly enhance the value of this testing. This course will review the history and preclinical regulatory requirements of medical devices and description planning and management of associated pre-clinical evaluations. In addition, the risks involved in medical device development and use are explored. Risk mitigation activities associated with development of an actual medical device are presented and then experienced through their application for a hypothetical medical device. Class time is devoted to providing feedback for individual student projects about mitigating the development risks for a student chosen real or hypothetical medical device.

3 Credits