Do not wait until the end of the project to fill out the checklist. Use it throughout the development life cycle. Conclusion
: Requires architectural design, integration testing, and detailed risk analysis.
Do not just write "Done" in the status column. Use the XLS cell formatting to link directly to your Jira tickets, GitHub/GitLab pull requests, or Greenlight/Matrix Requirements documentation.
Death or serious injury is possible — for example, ventilation control software. This class carries the full compliance burden of IEC 62304, including rigorous traceability, unit-level design documentation, code coverage analysis, and formal problem resolution processes.
of the checklist (e.g., Clause 5: Development). Explain SOUP management in more detail for your XLS. Compare requirements between Class B and Class C. Iec 62304 Checklist Xls
: Document all functional, performance, security, and interface requirements. Map these requirements back to user needs and system risks.
Disclaimer: This checklist is a guide based on IEC 62304:2006/AMD 1:2015. Always consult the official standard and a regulatory expert for project-specific needs.
Specific measures to mitigate identified risks. Verification: Evidence that control measures actually work. 3. Configuration & Problem Resolution (Clauses 8 & 9)
A well-structured XLS checklist should include columns for: Do not wait until the end of the
Medical software requires rigorous control even after launch.
As one regulatory template provider notes: “As with all regulatory documents, it‘s more about the content than about the tool. You don’t have to fill this checklist out every time in Word / GDocs / etc., but could embed it in your Jira / GitHub workflow” .
Update the checklist as you move through development phases (e.g., upon code completion, after testing).
Before shipping to manufacturing.
Checklist Items: Are release notes and installation instructions in place? 9. Software Maintenance and Risk Management
To make your checklist actionable, include the following columns in your spreadsheet:
Manages the finalized software, ensuring proper version control and documentation.
Standardizes the development process across teams. Do not just write "Done" in the status column