Medical Device Regulatory Affairs for Biomedical Engineers

2.0 credits · Graduate

This course is designed to provide a working knowledge of Medical Device Regulatory Affairs specifically for Biomedical Engineers. It is geared for both experienced biomedical engineering professionals as well as those new to the industry and is intended for non-regulatory professionals who need a better understanding of the regulatory requirements necessary to bring medical devices to market. This course demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialties. Strategies for using regulation as a competitive advantage will also be discussed. Instructor will be lecturing virtually (on-line) but in real-time.