ISO/TR 24971:2020 PDF

ISO/TR 24971:2020 provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.

The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016[24], but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019.

Edition :	2nd
File Size :	1 file , 6.2 MB
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	94
Published :	06/01/2020
Same As :	ISO/TR 24971:2020