Medical Device Design Control Training
Design controls are integrated management practices applied to the medical device development process, ensuring that the resulting device is safe, effective, and meets stakeholder requirements. In this class, you’ll learn strategies and best practices for managing these processes, thus ensuring that your organization’s devices meet user needs, intended uses, and specified regulatory requirements, including US FDA, ISO 13485, the Medical Device Single Audit Program (MDSAP) and the European Medical Device Regulation (MDR 2017/745).