Iec 62304 Checklist Xls Hot! Official
📋 IEC 62304 Checklist (copy into Excel)
| Clause | Activity / Requirement | Class A | Class B | Class C | Evidence / Artifact | Status | Comments | | --- | --- | --- | --- | --- | --- | --- | --- | | 4.3 | Software safety classification | ✅ | ✅ | ✅ | Classification report | ⬜ | | | 5.1 | Software development plan | ✅ | ✅ | ✅ | Development plan | ⬜ | | | 5.1.2 | Software life cycle model defined | ✅ | ✅ | ✅ | Life cycle description | ⬜ | | | 5.1.3 | Tailoring of activities | ✅ | ✅ | ✅ | Tailoring justification | ⬜ | | | 5.2 | Software requirements analysis | ✅ | ✅ | ✅ | Software requirements spec (SRS) | ⬜ | | | 5.2.6 | Risk control measures in requirements | ❌ | ✅ | ✅ | SRS + risk traceability | ⬜ | | | 5.3 | Software architectural design | ❌ | ✅ | ✅ | Architecture design document | ⬜ | | | 5.3.4 | Identify SOUP items | ❌ | ✅ | ✅ | SOUP list & risk assessment | ⬜ | | | 5.3.5 | Define segregation for risk control | ❌ | ✅ | ✅ | Architecture description | ⬜ | | | 5.4 | Software detailed design (unit design) | ❌ | ❌ | ✅ | Detailed design doc | ⬜ | | | 5.5 | Software unit implementation | ❌ | ❌ | ✅ | Code / unit implementation | ⬜ | | | 5.6 | Software integration & integration testing | ❌ | ✅ | ✅ | Integration plan & test results | ⬜ | | | 5.7 | Software system testing | ✅ | ✅ | ✅ | System test plan, cases, reports | ⬜ | | | 5.7.2 | Test risk controls | ❌ | ✅ | ✅ | Test traceability to risks | ⬜ | | | 5.8 | Software release | ✅ | ✅ | ✅ | Release notes & readiness review | ⬜ | | | 6.1 | Software maintenance plan | ✅ | ✅ | ✅ | Maintenance plan | ⬜ | | | 6.2 | Problem resolution process | ✅ | ✅ | ✅ | Bug tracking / CAPA records | ⬜ | | | 6.3 | Change request process | ✅ | ✅ | ✅ | Change control records | ⬜ | | | 7.1 | Risk management process (ISO 14971) | ✅ | ✅ | ✅ | Risk management file | ⬜ | | | 7.2 | Risk analysis of software hazards | ✅ | ✅ | ✅ | Hazard analysis / FMEA | ⬜ | | | 7.3 | Evaluate risk control measures | ❌ | ✅ | ✅ | Risk trace matrix | ⬜ | | | 8.1 | Software configuration management | ✅ | ✅ | ✅ | CM plan & version control | ⬜ | | | 8.2 | Problem resolution & traceability | ✅ | ✅ | ✅ | Problem reports & trend logs | ⬜ | | | 9.1 | Software verification plan | ✅ | ✅ | ✅ | Verification plan | ⬜ | | | 9.2 | Verification activities (reviews, tests) | ✅ | ✅ | ✅ | Review & test records | ⬜ | | | 9.3 | Traceability from requirements to tests | ✅ | ✅ | ✅ | Trace matrix | ⬜ | | | 9.4 | Software validation plan (user needs) | ✅ | ✅ | ✅ | Validation plan & report | ⬜ | | | Annex B | Documentation structure checklist | ✅ | ✅ | ✅ | Doc index / DHF | ⬜ | |
System Testing: Testing against the final software requirements. Release: Criteria for software versioning and distribution. 2. Risk Management (Clause 7) Iec 62304 Checklist Xls
An IEC 62304 compliance checklist is typically structured around Clauses 5 through 9: Software Development Process (Clause 5): Define the development lifecycle, tools, and roles. Requirements Analysis: 📋 IEC 62304 Checklist (copy into Excel) |
In conclusion, an IEC 62304 checklist xls is a valuable resource for medical device software developers, facilitating compliance with the IEC 62304 standard. By understanding the standard's requirements, creating and utilizing a checklist xls, and following best practices, organizations can ensure the quality and safety of their software products. Whether you're a seasoned developer or just starting out, incorporating an IEC 62304 checklist xls into your software development process will help you navigate the complex regulatory landscape and deliver high-quality medical device software. IEC 62304 Medical Device Software Standard Medical Device
For a practical .xls tool, organize your spreadsheet with these headers: IEC 62304 QMS Checklist for Medical Software Teams
Software Risk Management (Section 7): Analysis of software contributing to hazardous situations and risk control measures.
