IEC 62304 Software Lifecycle Toolkit — software development plan, SRS template, architecture design, unit verification protocol, problem resolution procedure, and safety classification worksheet.
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This toolkit is designed for teams facing these challenges:
Class A: no injury possible. Class B: non-serious injury possible. Class C: death or serious injury possible. The classification worksheet walks through the POSSIBLE HARM analysis with worked examples.
SOUP is pre-existing software incorporated without adequate development records. IEC 62304 requires documentation of SOUP version, published anomaly lists, and functional requirements. Most software uses open-source SOUP.
Download immediately after purchase. All templates are editable Word and Excel files.
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