Developed and taught by experienced personnel from the certification industry, this module aims to provide a broad regulatory foundation, exposure to the practical, real-world applications of the regulations, and an
appreciation of the important roles that regulatory affairs professionals play in the medical technology
industry. Throughout this course, the instructors will make learning more engaging with relevant examples and
hands-on exercises. It offers participants an opportunity to demonstrate an appreciation of the subjective and
interpretive aspects of the regulations and an ability to think critically about the interaction between regulatory and
development processes. Topics include FDA 21 CFR 820.30 and 501K, CE and ISO, CGMP, GCPs, GLPs, medical device vigilance, post-market surveillance (PMS), risk management, and preparing for certification auditing.