Post-market surveillance.
| | Requirement | Activity | Status | | --- | --- | --- | --- | | 5.1.1 | Software development planning | Create a software development plan | | | 5.1.2 | Software design | Create a software design document | | | 5.2.1 | Risk analysis | Perform a risk analysis | | | 5.3.1 | Verification and validation planning | Create a verification and validation plan | | Iec 62304 Checklist Xls
3, 4.3, "Software safety classification", Planning, "Classify software according to safety impact (Class A/B/C)", "Safety classification report, scoring rationale", "Classification justified per IEC 62304 definitions", Not Started, Safety Engineer, , , High, Post-market surveillance
= Required if the activity is performed or if it impacts safety. "Software safety classification"
The IEC 62304 Checklist is a structural tool used to ensure medical device software life cycle processes meet international standards for safety and compliance. It maps specific regulatory requirements to the documentation and activities required for different software safety classes.
Before shipping to manufacturing.
