| Source | Description | Link | |--------|-------------|------| | | Free "bare minimum" checklists for software requirements review and software release. Offered as editable Excel/Word files | openregulatory.com | | FDAToday | Free checklists including software release and software architecture checklists; specifically notes that templates are "designed to be used as an Excel or Sheets document" | fdatoday.com | | Elsmar Cove Forum | Community-updated IEC62304_Checklist.xls containing section headers with device class applicability | elsmar.com |
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Combining software units and testing them as a cohesive system. Iec 62304 Checklist Xls
Is your software or a standalone application (SaMD) ?
Years later, Sarah would often share the story of VitalPath with other startups. She’d remind them that while the path to regulatory compliance may be challenging, with the right tools and a clear roadmap, even the most ambitious dreams can become a reality. And at the heart of that roadmap, more often than not, was a well-crafted checklist. To help you build your own IEC 62304 compliance framework , let me know: Are you aiming for Software Safety Class A, B, or C Do you need specific column headers If you share with third parties, their policies apply
Zero exclusions allowed. Your spreadsheet must reflect rigorous detailed design descriptions down to individual module levels and exhaustive unit testing evidence. Steps to Implement and Execute Your IEC 62304 Spreadsheet
Medical software doesn't stop evolving once it hits the market. This tab tracks post-market modifications, bug fixes, and security patches. Combining software units and testing them as a
An Excel-based checklist (XLS) serves as a functional tool to audit your processes, track gaps, and prepare for regulatory submissions (such as FDA 510(k) or EU MDR CE marking).
Your checklist must account for these classes, as the required activities increase in rigor from Class A to Class C. IEC 62304: Medical Device Software Life Cycle Processes