Tracking the execution of integration test plans.
: Focuses primarily on high-level requirements, system testing, and configuration management. Detailed design (5.4) and unit testing (5.5) can be marked as N/A .
Optional additional sheets:
Ensuring regulatory or engineering stakeholders are informed if a critical issue is found. Iec 62304 Checklist Xls
39, 22.1, "End-of-life planning", Maintenance, "Define software end-of-life and transition plans", "EOL policy, customer notifications plan", "EOL criteria and communication defined", Not Started, Product Manager, , , Low,
37, 21.1, "Change impact analysis", Change Control, "Assess impact of changes on safety, performance, and regulatory status", "Change request, impact assessment", "Impact documented and approved", Not Started, Change Board, , , High,
IEC 62304 divides the software lifecycle into five distinct process groups, alongside underlying risk management and configuration tasks. Your XLS spreadsheet should feature separate tabs or clear visual sections matching these main headings. 1. Clause 5: Software Development Process Tracking the execution of integration test plans
This section intersects heavily with (Medical Device Risk Management). Software cannot cause physical injury on its own, but it can fail and cause a hardware failure or a clinical diagnostic error.
Record the specific version, patch level, and supplier details for all SOUP components used. Tab 4: Software Problem Resolution Process (Clause 8)
A color-coded dropdown menu containing options like Not Started (Red) , In Progress (Yellow) , Compliant (Green) , or Not Applicable (Gray) . "Validation of software in intended environment"
Cross-functional teams—comprising software devs, QA analysts, and legal consultants—can instantly access and review an XLS file without needing specialized software licenses.
Remember: content over format. If your checklist is maintained in Google Sheets, a markdown file in your git repository, or a dedicated eQMS module, the substance of what you track matters far more than the tool you use. With a well-structured IEC 62304 checklist in XLS format, medical device software compliance becomes not just achievable, but repeatable and sustainable.
31, 16.1, "Validation of software in intended environment", Validation, "Validate final software in intended use environment including clinical workflow", "Validation protocol, validation report", "Validation shows software meets user needs and intended use", Not Started, Validation Lead, , , High,
Extract the full clause list from IEC 62304:2015. A professional checklist will typically analyze each clause for key words indicating required activities.