FDA and EU Medical Device Software Regulations and Standards Training
This course provides a foundation for understanding the regulatory landscape for medical device software development. In this class, you will learn the regulatory requirements from the EU, US, and MDSAP countries including Australia, Canada, Brazil, and Japan. We cover requirements for submissions and software-related guidelines, plus the standards associated with software (ISO 13485, ISO 14971, and IEC 62304). The course also provides an overview of cloud computing in a regulated environment, plus current regulatory guidelines related to artificial intelligence and machine learning. Looking for more focus on IEC 62304? Consider this class.