Iec 62304 Checklist Xls

paper

I understand you're looking for a (i.e., a written document or template description) that outlines an IEC 62304 checklist in Excel (.xls) format . Since I cannot directly generate or attach an actual .xls file, I will provide you with a structured, copy-paste-ready table that you can easily import into Excel. This checklist covers the key activities and work products required by IEC 62304:2006 + A1:2015 (Medical device software – Software life cycle processes).

Responsible Person:

The team member assigned to verify the activity. Key Rows for the Checklist Iec 62304 Checklist Xls

• [ ] 5.6.1 – Are all software requirements mapped to a system test case? (RTM)
• [ ] 5.6.2 – Are you testing abnormal conditions (Out of memory, power loss)?
• [ ] 5.6.3 – For Class C: Have you performed 100% requirement traceability and risk-based testing?

Tab 4: Software Architecture & Detailed Design (Clause 5.3)

| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | M1 | 6.1 | Is there a process for receiving feedback? | How are post-market issues fed back into dev? | Complaint Handling SOP | | M2 | 6.2 | Are problem reports analyzed? | Assess impact on safety and determine classification. | Problem Report Analysis | | C1 | 8.1 | Is a Configuration Management Plan in place? | How is version control, branching, and merging handled? | CM Plan | | C2 | 8.2 | Are change records maintained? | Who made the change, when, and why? | Version Control Logs | | C3 | 8.3 | Is configuration status accounting performed? | Can you identify the exact configuration of any released version? | Release Manifests | paper I understand you're looking for a (i