BMEN 5100 - Standards and FDA Regulations

3 hours

Develop full understanding of US Food and Drug Administration (FDA) regulations that pertain to medical devices within the US, including requirements for manufacturers, importers, contract manufacturers and specification developers. Overview of translations between regulations and quality and industry standards and best practices. Develop an understanding of ISO 13485, the internationally-recognized standard followed by medical device companies globally. Introduction to regulations required by countries outside the USA including Canada and the European Union (EU). Introduction into requirements for clinical and pre-clinical testing. Overview of ethical and moral considerations for biomedical engineers entering into the medical device industry. Design project to include case study developing design history file documentation for the development of a medical device product to be developed.

Prerequisite(s): Graduate student in Biomedical Engineering or permission of instructor.

Course specific fees (in addition to tuition and mandatory):
Academic (AF) per hour: $73.70