What is IEC 62304?

IEC 62304 is an international standard that specifies life cycle requirements for the development of medical device software and software within medical devices. It is widely used by medical device manufacturers to ensure the safety, quality, and effectiveness of their software. The standard defines processes for software development, maintenance, risk management, configuration management, and problem resolution. Compliance with IEC 62304 is often required for regulatory approval of medical devices in many countries.