This is the core content for the spreadsheet. It outlines the specific activities required by the standard.
Serves as direct evidence for notified bodies and regulatory auditors, proving that every required lifecycle step was executed.
Define milestones and development environment.
This article is for informational purposes and does not constitute legal or regulatory advice. If you'd like, I can: Suggest in a vendor-provided checklist. Create a sample structure for your own XLS. Explain how to map this to ISO 13485. Iec 62304 Checklist Xls
IEC 62304 Compliance Checklist & Traceability Matrix Template
Focuses heavily on planning, requirements, system testing, configuration management, and bug resolution. Architectural design, detailed design, and formal integration testing are generally omitted.
: Outlining the roadmap for design and coding. This is the core content for the spreadsheet
| Phase | Key Checklist Items | |-------|---------------------| | | Document software development plan; define software system; identify standards; establish development methodologies; address safety classification | | Software Requirements Analysis | Document requirements; ensure traceability to system requirements; cover functional/performance/interface/security needs; ensure requirements are verifiable | | Software Architectural Design | Document architecture; identify all software items and interfaces; address segregation based on safety classification | | Software Detailed Design | Refine architecture into implementable units; provide algorithm descriptions and data structure definitions | | Software Implementation | Follow coding standards; conduct code reviews and inspections; version control | | Software Integration and Testing | Document integration test plan and results; test interface compatibility; verify component interaction | | Software System Testing | Document system test plan; verify all software requirements are met; trace tests to requirements | | Software Release | Confirm all documentation is current; verify risk management report is complete; ensure traceability is maintained; assign version number | | Software Maintenance | Establish problem resolution process; document change requests; evaluate impact of changes |
| 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 |
Standard checklists are typically organized into primary and supporting processes: Define milestones and development environment
Checklist Items: Are development, risk management, and configuration management plans documented? 2. Software Requirements Analysis
A acts as a traceability matrix and compliance tracking tool that maps the requirements of the IEC 62304 standard to your specific software project deliverables. It serves as:
| Item | Verified? (Yes/No) | Comment | |------|-------------------|---------| | Device Description | | | | Clinical Evaluation | | | | Declaration of Conformity | | | | Risk Management Report | | |
, meaning every row in her checklist now required the highest level of documentation. Phase 1: The Development Planning
Tip: Your XLS checklist should use columns to indicate which items apply to which class. Best Practices for Using an IEC 62304 Checklist XLS