This two-hour course provides a comprehensive overview of the regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way the U.S. is utilizing MDSAP.
By the end of this course, you should:
This course is essential for anyone wanting to bring a medical device or IVD to market in this specific jurisdiction, and also for employees in R&D, regulatory, quality and compliance functions.
By completing/passing this United States medical device regulations course, you will attain the Medical Device Certificate.