Iec 62304 Checklist Xls (Recent Strategy)

| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | Q1 | 4.1 | Has a Software Development Plan (SDP) been established? | Must define the life cycle model, deliverables, and traceability requirements. | SDP Document | | Q2 | 4.1 | Is a risk management process defined? | Must align with ISO 14971. | Risk Management Plan | | Q3 | 4.2 | Have the development standards been defined? | Define coding standards, comments, and naming conventions. | Coding Guidelines Doc | | Q4 | 4.3 | Has the Software Safety Class been determined? | Document the rationale for the classification. | Classification Report |

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Post-release feedback monitoring, bug evaluation, and controlled change management. Risk Management | ID | Clause | Activity / Checklist

An IEC 62304 checklist XLS is a valuable tool for ensuring compliance with the IEC 62304 standard for medical device software. By using a checklist, developers can ensure that all requirements and activities are addressed, reducing the risk of non-compliance and improving the safety and effectiveness of their software. The checklist provides a structured approach to software development, verification, and validation, and can help streamline audits and assessments. | Must align with ISO 14971

12, 6.4, "Software release testing (acceptance)", Verification, "Perform release/acceptance testing with release criteria", "Acceptance test reports, release checklist", "Release approval recorded", Not Started, Release Manager, , , High,