Iec 62304 Checklist Xls · Limited & Full

| 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 |

Medium risk; non-serious injury possible. Requires additional documentation like software architecture and detailed design. Iec 62304 Checklist Xls

6, 5.3, "Architectural design", Design, "Define high-level architecture, interfaces, modules, data flow", "Software architecture document, UML diagrams", "Architecture supports requirements and safety classification", Not Started, Lead Architect, , , High, | ID | Clause | Activity / Checklist

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