What is a Risk Management File?

ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]

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What is Probability of Failure of Medical Device Software?

One of the more controversial requirements of IEC 62304 is the probability of failure of medical device software during Risk Analysis. EN 62304:2006 paragraph 4.3 “Software Safety Classification” states “If the HAZARD could arise from a failure of the SOFTWARE SYSTEM to behave as specified, the probability of such failure shall be assumed to be […]

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Risk Management – part of a Quality Management System?

Risk Management is a key and mandatory part of a medical device development process. Unfortunately, Risk Management is often treated as merely an exercise required to achieve compliance rather than a tool to achieve an optimum design and to ensure the safety of the medical device. Let’s see how to get the best out of […]

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New Medical Devices Regulation & Risk Management

The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]

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SoftComply Risk Manager for Atlassian JIRA Cloud users now available!

SoftComply is pleased to announce that the first add-on for product risk management for JIRA Cloud users has arrived. SoftComply Risk Manager is a fully customizable risk management tool allowing users to identify, manage, mitigate, verify, trace and report product risks. Developed specifically for the needs of safety-critical product risk management, SoftComply Risk Manager provides […]

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Struggling with risk traceability in your safety critical product designs?

Coming up: the SoftComply Risk Manager! In most safety-critical product development projects, the product has to receive external agency approval and/or pass an audit prior to release to market. One of the aims of such an approval is to check whether the product is safe to use. In order to demonstrate this, it is usually […]

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