The standard enforces a risk-based framework. It requires manufacturers to classify software based on its potential to cause harm, and then apply specific engineering practices to ensure safety and effectiveness. The Role of an XLS Checklist in Compliance
22, 10.1, "Software problem resolution process (post-market)", Post-market, "Process for receiving and acting on field issues and incidents", "Post-market surveillance plan, incident handling SOP", "Incidents tracked; corrective actions implemented", Not Started, Vigilance Lead, , , High, Iec 62304 Checklist Xls