37, 21.1, "Change impact analysis", Change Control, "Assess impact of changes on safety, performance, and regulatory status", "Change request, impact assessment", "Impact documented and approved", Not Started, Change Board, , , High,
Identify and document any requirements that function as . Confirm all requirements are clear, testable, and complete. Writing Software Requirements Based on the IEC 62304 Iec 62304 Checklist Xls