: Test every single risk control measure to ensure it works reliably.
Before beginning the checklist, the Safety Class must be determined according to Clause 4.3.
Checklist Items: Are release notes and installation instructions in place? 9. Software Maintenance and Risk Management
Link problem resolutions back to Clause 7 (Change Control) to prevent regressions. Tab 5: Software Maintenance Process (Clause 9)
Your spreadsheet should be divided into the 5 core life cycle processes outlined by the standard. Module 5: Software Development Process Iec 62304 Checklist Xls
| Activity | Sub-activity | Class A | Class B | Class C | Method | Traceability | Status | | :--- | :--- | :---: | :---: | :---: | :--- | :--- | :--- | | | Test cases | ✘ | ✔ | ✔ | Automated/Manual | → Design spec | | | | Coverage (MC/DC) | ✘ | ✘ | ✔ | Analysis | | | | Integration verification | Interface testing | ✘ | ✔ | ✔ | Black/gray box | → Architecture | | | System testing | Functional testing | ✔ | ✔ | ✔ | Manual/Auto | → SRS | | | | Performance testing | ✘ | ✔ | ✔ | Benchmark | | | | | Stress/load testing | ✘ | ✘ | ✔ | Simulation | | | | Regression testing | After change | ✔ | ✔ | ✔ | Selective/full | → Change log | |
Thanks to the IEC 62304 Checklist XLS, Maria's team was able to deliver a high-quality software-controlled infusion pump that met all the relevant regulatory requirements. The pump was a success, and patients began to benefit from its precise and safe delivery of medication.
SOUP (Software of Unknown Provenance) refers to third-party components, open-source libraries, operating systems, and other off-the-shelf software integrated into your device. The standard requires you to specify SOUP's functional/performance requirements, document required system hardware/software, and evaluate whether SOUP is suitable for the intended use.
Conduct a gap analysis against the draft second edition, plan resources for potential reclassification, and align internal processes proactively. : Test every single risk control measure to
: Create a high-level architecture diagram. Identify Software Items, including Software of Unknown Provenance (SOUP), and define their interfaces (Required for Class B and C).
If you are preparing for an audit, I can help you that automate this checklist process, or compare the requirements for Class B versus Class C software . Share public link
IEC 62304 categorizes software based on the severity of injury it could inflict before risk mitigation measures are applied: No injury or damage to health is possible. Class B: Non-serious injury is possible. Class C: Death or serious injury is possible.
: Route all software patches or updates through the appropriate steps of the Clause 5 development process. Clause 7: Software Risk Management Process Module 5: Software Development Process | Activity |
, not just medical devices, including AI-based applications and solutions primarily for nursing and care without direct medical technology application.
Record the specific version, patch level, and supplier details for all SOUP components used. Tab 4: Software Problem Resolution Process (Clause 8)
Auditors (FDA, Notified Bodies) expect evidence of compliance.
Check how this aligns with quality systems on I3CGlobal .