| Item | Check | Comments |
|---|---|---|
| Design complies with intended use and requirements | ||
| Mechanical integrity and construction verified | ||
| Materials are biocompatible and safe | ||
| Electrical safety (if applicable) | ||
| Device labeling and instructions are clear | ||
| Usability/user interface validated | ||
| Risk assessment reviewed | ||
| Sterilization/cleanability evaluated | ||
| Functionality and performance tested | ||
| Regulatory requirements considered (e.g. FDA, CE) | ||
| Documentation complete and accurate |