Software Risk Management Series: The expectations of US regulations and for IEC 62304 compliance for software can be overwhelming. Software hazards analysis and risk management is certainly one of the more difficult tasks for developing medical devices containing software. In this post we discuss FTA and FMEA/FMECA methods. How do these methods align with specific software development activities?
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Third post on software risk analysis.
We often get asked about the use of Fault Tree Analysis (#FTA) and Failure Modes and Effects Analysis (#FMEA) methods to aid with analyzing risks associated with #software. Both methods are extremely helpful in the process and I really can’t… pic.twitter.com/4kFkA4yeCq— @softwarecpr (@softwarecpr) February 12, 2025
