| ID | Clause | Activity / Checklist Item | Guidance Notes | Actionable Output | | :--- | :--- | :--- | :--- | :--- | | M1 | 6.1 | Is there a process for receiving feedback? | How are post-market issues fed back into dev? | Complaint Handling SOP | | M2 | 6.2 | Are problem reports analyzed? | Assess impact on safety and determine classification. | Problem Report Analysis | | C1 | 8.1 | Is a Configuration Management Plan in place? | How is version control, branching, and merging handled? | CM Plan | | C2 | 8.2 | Are change records maintained? | Who made the change, when, and why? | Version Control Logs | | C3 | 8.3 | Is configuration status accounting performed? | Can you identify the exact configuration of any released version? | Release Manifests |
16, 8.2, "Identification and control of baselines", CM, "Define items under configuration control and baselines", "Baseline records, change records", "Baselines approved and auditable", Not Started, CM Manager, , , High,
Users can apply filters to hide or display clauses based on whether the software is designated Class A, B, or C, saving hundreds of hours of irrelevant documentation work. Iec 62304 Checklist Xls
You can find downloadable .xls and .doc templates from the following providers:
I can provide tailored row items or formula suggestions for your . Share public link | ID | Clause | Activity / Checklist
IEC 62304 defines the life cycle requirements for medical device software. It covers the development, maintenance, risk management, and configuration management of software, ensuring it performs safely.
IEC 62304:2006 + A1:2015 is the internationally recognized functional safety standard that defines the life cycle processes for medical device software. It focuses on ensuring that software is developed systematically to minimize risks to patients. Software Safety Classifications | Assess impact on safety and determine classification
The classification applies per software component —the highest class among any component determines the class for the entire system. Risk control measures outside the software can reduce the classification (e.g., hardware interlocks or redundant backup systems), which reduces documentation effort. However, if no classification is performed, the software defaults to Class C.
26, 12.2, "Record retention", Documentation, "Define retention periods and storage for lifecycle records", "Records retention schedule", "Records retained per regulatory requirements", Not Started, QA, , , Low,
Below is a structured, comprehensive IEC 62304 compliance checklist you can paste into an Excel file. Each row represents one checklist item with suggested columns for tracking status, evidence, owner, and notes. Use the "Status" column values: Not Started / In Progress / Complete / Not Applicable. Adjust or remove columns to match your project process.
