The global nature of the medical device industry presents both opportunities and challenges to medical device companies and regulatory affairs professionals who must navigate a diverse regulatory terrain. Through interactive lectures and facilitated group projects, students gain a practical understanding of international medical device requirements and regulations for major and emerging markets around the world, with emphasis on the EU, Canada, Japan, and China. A comparative approach highlights regulatory and process similarities and differences between countries and underscores the impact they have on global regulatory and business strategies. This course will benefit regulatory affairs professionals who need to help their organizations understand the barriers to entry into global medical device market.
Instructional Team:
CRAIG J. COOMBS, RAC, president of Coombs Medical Device Consulting, has more than 20 years of experience in the medical device industry. He has been a consultant since 1997 and is frequently called on to develop innovative U.S. and European regulatory strategies; provide guidance in device failure analysis and procedures; and develop and implement transitional or crisis project management in regulatory, clinical and/or quality arenas.
STACEY ELLUL, M.B.A. has a background in clinical nursing within intensive and critical care specializations. Following a progressive clinical career, she completed a Masters in Business Administration and transitioned her clinical skills to the medical device industry. Stacey now manages International Regulatory Affairs for the Cardiac Rhythm Management Division of St. Jude Medical, where she is responsible for a team of Regulatory Affairs Specialists who register products within EU for CE Mark and within all global markets including Canada, Latin America, Australia, Japan, China, Korea and South East Asia.
"Regulation of Medical Devices and Diagnostics" or equivalent course or work experience.
