What is iso14971 a system
ISO14971 is Risk Management for Medical Devices, SGS provides ISO14971 Risk Management for Medical Devices is a risk management standard for medical devices and in vitro diagnostic medical devices.ISO14971:2019 was published in December 2019.The standard's requirements apply to all stages of the product lifecycle from conception to late-stage production, with a greater emphasis on the expected medical device benefit of use, further balancing the relationship between risk and benefit of the device, and more explicit and specific requirements to enhance the readability and usability of the standard.