ISO 62304 Insights

What is ISO 62304?

ISO 62304 is an international standard specifying the life cycle requirements for the development of medical device software and software as a medical device (SaMD). It provides a framework for software development, maintenance, and risk management to ensure the safety and effectiveness of medical device software. It is commonly used by medical device manufacturers to demonstrate compliance with regulatory requirements and to improve the quality of their software.

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What other technologies are related to ISO 62304?

ISO 62304 Complementary Technologies

ISO 14971

ISO 14971 specifies requirements for a risk management system to manage risks associated with medical devices. It is complementary to ISO 62304 as it provides the risk management framework that should be applied throughout the software development lifecycle defined in ISO 62304.

mentioned alongside ISO 62304 in 2% (76) of relevant job posts

ISO 13485

ISO 13485 specifies requirements for a quality management system specific to the medical device industry. While ISO 62304 focuses on software lifecycle processes, ISO 13485 provides the broader quality management system framework within which ISO 62304 can be implemented for medical device software.

mentioned alongside ISO 62304 in 1% (96) of relevant job posts