Medical Devices ...and More
The medical device industry is one of the most vibrant and important drivers of the health care economies. Regulations to ensure the safety of devices and in vitro diagnostics are evolving rapidly in the international arena. In this course, participants with a basic knowledge of biomedical science and regulatory structures will explore in depth the policies and practices of regulatory research, review, and management for these product classes. At the completion of the course, participants will exhibit a detailed understanding of international standards and practices in relation to local laws, policies, and regulations. They will be able to integrate this knowledge with scientific principles related to the development of experimental protocols and testing paradigms, in order to plan, critique and provide direction to complex device programs.
Audits and the MSDAP Program (PowerPoint slides only)