BME 4103 BME Quality & Regulatory Compliance

In today's dynamic healthcare landscape, the development and production of medical devices are subject to rigorous regulatory frameworks. This course explores the intricate world of quality management and regulatory compliance within the biomedical engineering field. Students will gain foundational knowledge and insights into the essential federal laws and regulations that govern every facet of medical device lifecycle – from inception to market deployment.

Credits

3

Lab Hours

0

Lecture Hours

3

Prerequisite

Junior Standing or Department Chair Permission