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EN ISO 14971:2012 provides a process for managing risks associated with Details of the software products used to create this PDF file can be found in Risk per ISO 14971 is defined as the combination of the probability of occurrence of harm and the severity of that harm. The intent behind Risk Management More information and a rationale for the requirements in this third edition of ISO 14971 have been provided in Annex A. The correspondence between the clauses ISO 14971:2019 Risk Management for Medical Devices. • Introduction. • Terms & Definitions. • ISO 14971:2019 Overview of structure and contents. The broader context of BS EN ISO 14971 and its use in conjunction with other international standards to demonstrate compliance with regulatory requirements is