The medical device market changes frequently in terms of technology, risk potential, marketing and reimbursement. Therefore, it is imperative for regulatory professionals to be aware of existing requirements and new developments in the global market. As a participant you will learn how to ask the right questions and adapt the course concepts to your own organization.
This course provides a basic description of global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful global strategies for medical devices, including definitions and classifications worldwide, elements of regulatory strategy, sources of competitive and regulatory intelligence, selection of development and product approval pathways and suggestions for professional development.