IEC 62304 is an international standard that provides guidance on the software development lifecycle for medical device software. The standard is titled “Medical device software – Software life cycle processes” and was developed by the International Electrotechnical Commission (IEC).
IEC 62304 provides a framework for the development of medical device software, including requirements for software development planning, software design and implementation, software verification and validation, software maintenance, and software risk management. The standard emphasizes the importance of a well-defined software development process and the use of appropriate controls to ensure software quality and safety.
IEC 62304 is widely recognized as a key standard for the development of medical device software and is used by regulatory agencies around the world, including the U.S. Food and Drug Administration (FDA) and the European Union Medical Device Regulation (MDR). compliance with IEC 62304 is often a requirement for the approval and market clearance of medical devices that include software.
The standard is intended to be used by software developers, quality assurance professionals, regulatory affairs personnel, and others involved in the development and approval of medical device software.
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