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ISO/TR 18965:2025

Medical devices - Examples of the application of the risk management process to cardiac valve replacement and repair systems
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This document illustrates the implementation of the risk management process to the total product life cycle of cardiac valve replacement and repair systems. It provides specific examples of how risk management requirements and concepts can be applied to new or modified cardiac valve replacement and repair systems. The informative examples included herein are not exhaustive.

SDO ISO: International Organization for Standardization
Document Number ISO/TR 18965
Publication Date Jan. 1, 2025
Language en - English
Page Count 26
Revision Level
Supercedes
Committee ISO/TC 150/SC 2
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