⚠️ Important: This checklist is a template. For Class C software, you must also address:
An IEC 62304 Checklist is an essential tool for medical device software teams to track compliance with the international standard for software life cycle processes. While many teams start with an Excel (.xls) spreadsheet for its ease of use, modern regulatory expectations often require more robust traceability. Core Compliance Checklist Categories
A comprehensive checklist is typically organized by the major clauses of the standard (Clauses 5–9): Software Development Process (Clause 5):
Development Planning: Establish a plan including life cycle activities and documentation.
Requirements Analysis: Define functional, performance, and safety requirements.
Architecture & Detailed Design: Create diagrams for subsystems and, for Class C, complete detailed designs. Iec 62304 Checklist Xls
Verification: Perform unit verification, integration testing, and system testing.
Software Maintenance (Clause 6): Establish procedures for evaluating problem reports and assessing the impact of changes on safety.
Risk Management (Clause 7): Perform software-specific hazard analysis and implement risk control measures.
Configuration Management (Clause 8): Identify configuration items (source code, SOUP, specifications) and establish baselines.
Problem Resolution (Clause 9): Document a process for investigating and resolving anomalies. Software Safety Classifications Freeze the top row in each sheet
To create a functional IEC 62304 Compliance Checklist in Excel (XLS), your spreadsheet should be structured to map the standard's clauses against your software safety classification (A, B, or C) and your internal documentation. Recommended XLS Column Structure
A professional checklist typically uses these eight columns to ensure audit readiness: I. Reference: Clause number (e.g., 5.1.1). II. Software Lifecycle Process: Brief description of the requirement/task. III–V. Applicability (Class A, B, C): Mark "X" if the clause applies to that safety class. VI. Supporting Document(s): Name/ID of your internal SOP, Plan, or Report. VII. Specific Section: Exact page or section in your document for easy navigation. VIII. Status/Comments: Current compliance status (e.g., Compliant, Gap, N/A). Key Content for Checklist Rows
You should organize your rows by the five core process areas (Clauses 5–9): Process Area Key Checklist Items Development
Planning, requirements analysis, architecture design, unit implementation/verification, integration testing, system testing, and release. Maintenance
Post-release feedback monitoring, bug evaluation, and controlled change management. Risk Management ⚠️ Important: This checklist is a template
Software hazard analysis, risk control implementation, and verification of mitigations. Configuration
Identifying configuration items, version control, change control, and configuration audits. Problem Resolution
Tracking reports, root cause analysis, and documenting corrective actions. Important Implementation Details IEC 62304 QMS Checklist for Medical Software Teams
| Clause | Activity / Work Product | Safety Class A | Safety Class B | Safety Class C | Evidence / Artifact | Status | Comments | |--------|------------------------|----------------|----------------|----------------|----------------------|--------|----------| | 4.3 | Software development plan | Yes | Yes | Yes | Development plan document | | | | 4.4 | Software configuration management plan | Conditional | Yes | Yes | CM plan | | | | 5.1.1 | Software requirements specification | Yes | Yes | Yes | SRS document | | | | 5.1.2 | Analyze software requirements | Yes | Yes | Yes | Requirements review record | | | | 5.2.1 | Software architectural design | No | Yes | Yes | Architecture design doc | | | | 5.2.2 | Identify SOUP items | No | Yes | Yes | SOUP list & risk assessment | | | | 5.2.3 | Allocate requirements to software units | No | Yes | Yes | Traceability matrix | | | | 5.2.4 | Define interfaces | No | Yes | Yes | Interface specification | | | | 5.2.5 | Verify architecture | No | Yes | Yes | Architecture review report | | | | 5.3.1 | Software detailed design | No | Conditional | Yes | Detailed design doc | | | | 5.3.2 | Develop software units | No | Conditional | Yes | Code / models | | | | 5.3.3 | Verify detailed design & units | No | Conditional | Yes | Design/code reviews | | | | 5.4.1 | Software integration plan | No | Yes | Yes | Integration plan | | | | 5.4.2 | Integrate software units | No | Yes | Yes | Integration records | | | | 5.4.3 | Verify integration | No | Yes | Yes | Integration test report | | | | 5.5.1 | Software system test plan | Yes | Yes | Yes | System test plan | | | | 5.5.2 | Test software requirements | Yes | Yes | Yes | Test cases & results | | | | 5.5.3 | Document test results | Yes | Yes | Yes | Test report, issue log | | | | 5.6.1 | Prepare for software release | Yes | Yes | Yes | Release notes, version | | | | 5.6.2 | Deliver software | Yes | Yes | Yes | Delivery records | | | | 5.7.1 | Establish problem resolution process | Conditional | Yes | Yes | Issue tracking system | | | | 5.7.2 | Analyze & resolve problems | Conditional | Yes | Yes | Problem reports, change requests | | | | 5.7.3 | Track problems | Conditional | Yes | Yes | Problem resolution log | | | | 5.8 | Software configuration management | Conditional | Yes | Yes | Version control, baseline records | | | | 6 | Software maintenance process | Yes | Yes | Yes | Maintenance plan, change records | | | | 7 | Software risk management (see ISO 14971) | Yes | Yes | Yes | Risk management file | | | | 8 | Documentation (compliance evidence) | Yes | Yes | Yes | Document index, trace matrix | | | | Annex A | SOUP acceptance | No | Yes | Yes | SOUP validation report | | |
Conditional = Required if the activity is performed or if it impacts safety.
You might ask: Why not use expensive ALM tools? While tools like Jira or Polarion are powerful, an Excel checklist remains the industry standard for small to mid-sized companies for three reasons:
A properly built IEC 62304 XLS checklist serves as your Master Verification Matrix.