Disclaimer: This article is for informational purposes and does not constitute legal or regulatory advice. Always consult the full IEC 62304 standard text and a qualified regulatory consultant for your specific device.
In the world of Medical Device Software (SaMD and SiMD), the difference between market approval and a costly recall often comes down to documentation. IEC 62304 is the benchmark standard for software lifecycle processes, harmonized by regulatory bodies like the FDA (US) and notified bodies under the MDR (Europe).
Is your software or a standalone application (SaMD) ?
Do not use a random "free download" from an unverified website. The standard was updated with Amendment 1 (2015) clarifying software system testing. Ensure your checklist references IEC 62304:2006 + AMD1:2015 .
Specific measures to mitigate identified risks. Verification: Evidence that control measures actually work. 3. Configuration & Problem Resolution (Clauses 8 & 9) Iec 62304 Checklist Xls
An tracks compliance across the software development lifecycle for medical devices. To build an effective XLS tool, you must categorize requirements by Software Safety Class (A, B, or C) to determine which activities are mandatory. 🛠️ Core XLS Structure
Tracks how bugs and user defects are managed during and after development.
Ensure your spreadsheet maps requirements directly to code units, risk hazards, and test protocols. A "Traceability Matrix" tab is highly recommended.
Verifies the final compiled software against the original Software Requirements Specification (SRS). Applies to Classes A, B, and C. Disclaimer: This article is for informational purposes and
Medium risk; non-serious injury possible. Requires additional documentation like software architecture and detailed design.
Fill in the SOP Reference column. Ensure your software procedures map seamlessly to your overall company-wide ISO 13485 framework.
Link problem resolutions back to Clause 7 (Change Control) to prevent regressions. Tab 5: Software Maintenance Process (Clause 9)
A comprehensive checklist typically covers the five primary processes defined in the standard: Software Development Process (Clause 5): IEC 62304 is the benchmark standard for software
IEC 62304 comprises several key components, including:
For software safety classes B and C, Clause 5.3.6 requires verification of the architecture design. Your checklist should confirm that:
A truly useful checklist goes beyond a simple list of clauses. It should include:
Standard checklists are typically organized into primary and supporting processes:
| Clause | Requirement | Class A | Class B | Class C | Status | Evidence / Artifact | Date | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | | Software development plan | ✔ | ✔ | ✔ | | Plan document | | | 5.1.1 | Define software requirements | ✔ | ✔ | ✔ | | SRS document | | | 5.1.2 | Analyze software requirements for risk | ✘ | ✔ | ✔ | | Risk assessment | | | 5.1.3 | Define architecture | ✘ | ✔ | ✔ | | Architecture design | | | 5.1.4 | Detailed design (units) | ✘ | ✘ | ✔ | | Detailed design spec | | | 5.1.5 | Implement units | ✔ | ✔ | ✔ | | Code / components | | | 5.1.6 | Verify units (unit testing) | ✘ | ✔ | ✔ | | Unit test report | | | 5.1.7 | Integrate software | ✔ | ✔ | ✔ | | Integration plan | | | 5.1.8 | Verify integration | ✘ | ✔ | ✔ | | Integration test | | | 5.1.9 | System testing | ✔ | ✔ | ✔ | | System test report | | | 5.2 | Maintenance process | ✔ | ✔ | ✔ | | Maintenance plan | | | 5.3 | Problem resolution | ✔ | ✔ | ✔ | | Issue tracking log | | | 5.4 | Configuration management | ✔ | ✔ | ✔ | | CM plan / tool | | | 5.5 | Change control | ✔ | ✔ | ✔ | | Change request log | |