IEC 62304 Insights

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.

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What other technologies are related to IEC 62304?

IEC 62304 Complementary Technologies

ISO 14971

ISO 14971 specifies requirements for a risk management system to manage risks associated with medical devices, including software. It's a crucial standard for ensuring the safety of medical devices developed according to IEC 62304.

mentioned alongside IEC 62304 in 31% (988) of relevant job posts

IEC 62366

IEC 62366 (now IEC 62366-1) focuses on usability engineering for medical devices. Software developed according to IEC 62304 must be usable, making IEC 62366 a complementary standard.

mentioned alongside IEC 62304 in 66% (341) of relevant job posts

ISO 13485

ISO 13485 specifies requirements for a quality management system specific to the medical device industry. IEC 62304 fits into the overall quality management system for software development.

mentioned alongside IEC 62304 in 10% (1.2k) of relevant job posts