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Medical Device Risk Management ISO 14971 Dan O'Leary President Ombu Enterprises, LLC Dan@OmbuEnterprises.com OmbuEntThis PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the entry: The accompanying documentation can consist of the instructions for use, technical description, installation manual, quick reference guide, etc. ISO 14971:2019 Risk Management for Medical Devices ISO 14971:2019 Overview of structure and contents manual, quick reference guide, etc. The broader context of BS EN ISO 14971 and its use in conjunction with other international standards to demonstrate compliance with regulatory requirements is 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

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