Tracks how bugs and user defects are managed during and after development.
If you are building your own XLS, ensure you include these columns for every requirement: : (e.g., REQ-001) Description : What the software must do. Safety Class : (A, B, or C) : Linking it to your Risk Management File (ISO 14971). : Where the requirement is addressed in the architecture. Test Case ID : The proof that it works. : (Open, In Progress, Verified) software versus Class C?
Search for "IEC 62304 Template Bundle" from vendors like:
: Analyze the specific risks introduced by using third-party, commercial, or open-source software libraries. Clause 8: Software Configuration Management Process Iec 62304 Checklist Xls
The specific team member or role assigned to execute and verify the clause.
Determine if feedback affects safety or performance.
Do you need assistance mapping specific clauses into this spreadsheet? Tracks how bugs and user defects are managed
: The specific section number from the IEC 62304 standard (e.g., 5.1.1).
SOUP (Software of Unknown Provenance) refers to third-party components, open-source libraries, operating systems, and other off-the-shelf software integrated into your device. The standard requires you to specify SOUP's functional/performance requirements, document required system hardware/software, and evaluate whether SOUP is suitable for the intended use.
"Document software capability, performance, and security requirements." Indicates which classes must comply Compliance Status Current state of the requirement Dropdown: Compliant, Non-Compliant, N/A, In Progress Artifact / Document Reference Path or ID of the proving document SRS-Doc-V2.1, Section 3.4 Owner / Reviewer Team member responsible for verification Jane Doe (QA Engineer) Comments / Gaps Notes on outstanding tasks or justifications : Where the requirement is addressed in the architecture
Document functional, performance, and risk-related software requirements. Architecture & Design:
. Here is how that checklist turned their chaotic "crunch time" into a smooth path to certification. The Foundation: Software Safety Classification