^hot^ — Iec 62304 Checklist Xls
The is not just a bureaucratic exercise; it is your map through the regulatory wilderness. Without it, you risk 510(k) denials, MDR technical file rejections, and painful audit non-conformities.
| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | | | | | | | D1 | 5.1.1 | Are input requirements defined? | Capture functional, interface, and performance requirements. | SRS Document | | D2 | 5.1.2 | Are requirements traceable? | Each requirement needs a unique ID. | Traceability Matrix | | D3 | 5.1.3 | Is the content of the SRS complete? | Must include functional, safety, security, and user interface requirements. | Approved SRS | | Design | | | | | | D4 | 5.2 | Has the software architecture been documented? | Define system components, interfaces, and data flows. | Architecture Diagrams | | D5 | 5.3.1 | Has the software detailed design been developed? (Class B/C) | Refine architecture to the unit level. | Detailed Design Docs | | D6 | 5.3.4 | Is there a correspondence between requirements and design? | Verify that every requirement is covered by the design. | Traceability Matrix | | Implementation | | | | | | D7 | 5.4 | Is source code implemented according to design? | Developers must follow coding standards defined in Q2. | Source Code Repo | | D8 | 5.4.2 | Are contributions to the architecture/design recorded? | If coding reveals a design flaw, update the design docs. | Change Request | | Testing | | | | | | D9 | 5.5 | Are Unit Tests defined and executed? (Class B/C) | Test each software unit (function/class) in isolation. | Unit Test Reports | | D10 | 5.6 | Is Integration Testing performed? | Verify interfaces between units/modules. | Integration Test Report | | D11 | 5.7 | Is System Testing performed? | Test against the SRS requirements in the target environment. | System Test Report | | D12 | 5.7.4 | Are regression tests performed after changes? | Ensure changes did not break existing functionality. | Regression Test Report | Iec 62304 Checklist Xls
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, The is not just a bureaucratic exercise; it
Specific measures to mitigate identified risks. Verification: Evidence that control measures actually work. 3. Configuration & Problem Resolution (Clauses 8 & 9) | Traceability Matrix | | D3 | 5
| Clause | Requirement | Class A | Class B | Class C | Status | Evidence / Artifact | Date | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | | Software development plan | ✔ | ✔ | ✔ | | Plan document | | | 5.1.1 | Define software requirements | ✔ | ✔ | ✔ | | SRS document | | | 5.1.2 | Analyze software requirements for risk | ✘ | ✔ | ✔ | | Risk assessment | | | 5.1.3 | Define architecture | ✘ | ✔ | ✔ | | Architecture design | | | 5.1.4 | Detailed design (units) | ✘ | ✘ | ✔ | | Detailed design spec | | | 5.1.5 | Implement units | ✔ | ✔ | ✔ | | Code / components | | | 5.1.6 | Verify units (unit testing) | ✘ | ✔ | ✔ | | Unit test report | | | 5.1.7 | Integrate software | ✔ | ✔ | ✔ | | Integration plan | | | 5.1.8 | Verify integration | ✘ | ✔ | ✔ | | Integration test | | | 5.1.9 | System testing | ✔ | ✔ | ✔ | | System test report | | | 5.2 | Maintenance process | ✔ | ✔ | ✔ | | Maintenance plan | | | 5.3 | Problem resolution | ✔ | ✔ | ✔ | | Issue tracking log | | | 5.4 | Configuration management | ✔ | ✔ | ✔ | | CM plan / tool | | | 5.5 | Change control | ✔ | ✔ | ✔ | | Change request log | |