What (Agile, Waterfall, V-Model) do you follow?
15, 8.1, "Configuration management plan", CM, "Establish CM for software items: baselines, versioning, build control", "CM Plan, baselined repository", "Source, deliverables, and baselines controlled", Not Started, CM Manager, , , High,
An is not just an administrative task; it is a critical tool for navigating the complexities of medical device software compliance. By mapping your development processes against the standard's requirements, you ensure a safe, high-quality, and audit-ready product. Iec 62304 Checklist Xls
Track risks introduced by third-party software, libraries, or operating systems, evaluating potential anomalies and impacts on system safety. Tab 3: Software Configuration Management Process (Clause 7)
Store the spreadsheet in your controlled Quality Management System (QMS) or a Git repository alongside your source code. Baseline the checklist with every major release milestone. What (Agile, Waterfall, V-Model) do you follow
19, 9.1, "Risk management integration", Risk, "Integrate ISO 14971-based risk management with software lifecycle", "Risk management plan, risk file (hazards, mitigations, residual risk)", "Risks identified, controls implemented and verified", Not Started, Risk Manager, , , High,
48, 31.1, "Traceability to system-level risk controls", Risk, "Ensure software contributes to and verifies system-level risk controls", "Trace matrix linking system risk controls to software functions", "All system risk controls implemented or noted as N/A", Not Started, Safety Engineer, , , High, Dropdown menu containing Compliant
: Tracking "Software of Unknown Provenance" (third-party libraries).
Verify that system requirements are properly translated into software requirements. Check for proper categorization (functional, safety, security, interfaces).
Dropdown menu containing Compliant , In Progress , Not Started , or Not Applicable .