What concerns FDA when conducting a benefit-risk assessment of medical devices? The answer is a long list of variables that can vary by type of device, target population, and indications for use, but the clear focus is on patient safety and benefit. The FDA considers both the device benefit-risk assessment, as well as evidence and...Read More
In SoftwareCPR’s opinion, a somewhat unique, very well conceived, and well designed tool for the specialized craft of risk analysis as well as safety assurance cases. The tool is very configurable, allowing customized structures for your own methods. The ability to view data from an FMEA, FTA, or table view saves valuable time during creation...Read More
This content is only available to Standards Navigators subscribers. See our Subscribe page for information on subscriptions. The link provides the formal objection to the harmonization of ISO 14971 from the European Commission. EN Deharmonization of Cen-Standards 2010-11Read More
This content is only available to Standards Navigators subscribers. See our Subscribe page for information on subscriptions. The link provides the response from ISO TC 210 to the EC objections to ISO 14971. ISO TC210 Comments on deharmonization of EN14971Read More
This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed. This example is modeled on the approach required by ISO 14971 and expands on it with...Read More
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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.