| | Description | Completed | | --- | --- | --- | | 1.1 | Conduct requirements analysis | | | 1.2 | Create software design | | | 1.3 | Implement software | | | 2.1 | Conduct verification activities | | | 2.2 | Conduct validation activities | | | 3.1 | Perform risk analysis | | | 3.2 | Perform risk assessment | | | 4.1 | Create configuration management plan | | | 5.1 | Create quality management plan | |
(Classes B & C) Confirm that architectural designs define interfaces between software items and identify SOUP items.
I hope this helps! Let me know if you'd like me to expand on any section.
If you are preparing for an audit, I can help you that automate this checklist process, or compare the requirements for Class B versus Class C software . Share public link Iec 62304 Checklist Xls
Hosts several community-uploaded IEC 62304 Checklists in Excel format.
| 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 |
Ensure software items contributing to hazardous situations are clearly linked to the overall hazard analysis. | | Description | Completed | | --- | --- | --- | | 1
Are trends analyzed and the root cause determined for critical issues? Applicability: Classes A, B, C.
While ALM (Application Lifecycle Management) tools exist, an remains popular for several reasons:
Document software-based risk controls (e.g., fail-safes, bounds checking, alarms). If you are preparing for an audit, I
26, 12.2, "Record retention", Documentation, "Define retention periods and storage for lifecycle records", "Records retention schedule", "Records retained per regulatory requirements", Not Started, QA, , , Low,
Do you need assistance mapping specific clauses into this spreadsheet?