BMDE 654 — Biomedical Regulatory Affairs - Medical Devices

Regulatory strategies and quality management systems are critical for medical device development. This course provides an overview of regulatory requirements, and familiarize students with the important ISO and IEC standards pertaining to medical device development. This course will provide biomedical engineers with an understanding of the regulatory and quality requirements to translate a medical device idea into a commercial product, and will draw upon the expertise of invited speakers currently working in the medical devices industry.

• Credits: 3
• Faculty: Graduate Studies
• Department: Biomedical Engineering
• Taught by: Danny Kroo

Sections offered

• Section 001 (Lec), Thu 4:05-6:55 pm — 2 seats open