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Explore the complex regulatory landscape governing medical software approval in this 16-minute lesson from Yale University. Learn how regulatory agencies evaluate medical software based on efficacy, safety, and security principles, and discover how risk classification determines the appropriate approval pathway. Master the distinctions between device classifications (Class I, II, III) and their corresponding review processes, including 510k, De Novo, and Pre-Market Approval (PMA) procedures in the United States. Understand the application of general controls versus special controls in medical device regulation, and gain comprehensive knowledge of how regulatory frameworks differ across major markets. Compare the approval processes and requirements for medical software under the FDA in the United States, the Medical Device Regulation (MDR) in the European Union, and the National Medical Products Administration (NMPA) in China, equipping yourself with essential knowledge for successfully bringing medical software products to market across these key regulatory jurisdictions.
