ISO 14971
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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.
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.
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.
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.
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Which job functions commonly mention ISO 14971?
Public Policy
0.4% of all Public Policy jobs mention ISO 14971
View 432
jobs on Sumble
Quality Engineer
0.3% of all Quality Engineer jobs mention ISO 14971
View 745
jobs on Sumble
Quality Assurance
0.1% of all Quality Assurance jobs mention ISO 14971
View 484
jobs on Sumble
Test Engineer
0.1% of all Test Engineer jobs mention ISO 14971
View 97
jobs on Sumble
Engineer
1501 Engineer jobs mention ISO 14971
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jobs on Sumble
Which organizations are mentioning ISO 14971?
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