ISO 14971 Insights

What is ISO 14971?

ISO 14971 is an international standard for the application of risk management to medical devices. It specifies a process for manufacturers to identify hazards associated with medical devices, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. It is commonly used to ensure the safety of medical devices throughout their lifecycle.

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What other technologies are related to ISO 14971?

ISO 14971 Complementary Technologies

ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 14971 is often a key component of a quality management system conforming to ISO 13485.

mentioned alongside ISO 14971 in 20% (2.4k) of relevant job posts

IEC 62304

IEC 62304 specifies requirements for the software lifecycle for medical device software. Risk management, as defined in ISO 14971, is an integral part of the software development process according to IEC 62304.

mentioned alongside ISO 14971 in 43% (988) of relevant job posts

IEC 62366

IEC 62366 specifies requirements for usability engineering of medical devices. Risk management (ISO 14971) is used to evaluate the risks associated with usability issues.

mentioned alongside ISO 14971 in 65% (336) of relevant job posts