Medical Device Approval Primer

Medical Device Approval Primer takes a close look at the complex world of regulatory approval pathways. With a focus on the FDA and EMA agencies, it identifies the regulatory compliance requirements and different medical device classifications, from Class I to III, that are critical to ensuring patient safety. This primer provides insight into the FDA and EMA organizational structure and approval pathways, such as 510(k), De Novo 510(k), PMN, and PMA. Learn about the importance of Quality System Regulations (QSR) requirements, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) used worldwide in medical device development. Become fluent in assessing risk and choosing the appropriate medical device approval pathway―grab your seat today!