![]() ![]() ![]() The ISO 14791 describes a process which is effective for creating medical devices that are safe. Also, there are some overlaps between the two: Compliance and operational risks are generally the same, Operational risk management can be used for compliance risk. They are two disciplines which are interrelated. The difference between Compliance Risk Management and Product Risk Managementīoth 'Compliance risk management' and 'Product risk management' are responsibilities of a regulated firm but they are not mutually exclusive responsibilities. ![]() This article sets the stage for the greater understanding of Risk management and provides an overview of ISO 14791.
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