Iec 62304 Checklist Xls [portable]

Specific measures to mitigate identified risks. Verification: Evidence that control measures actually work. 3. Configuration & Problem Resolution (Clauses 8 & 9)

Planning, requirements analysis, architecture design, unit implementation/verification, integration testing, system testing, and release. Maintenance Iec 62304 Checklist Xls

Organize your spreadsheet with these headers for clear traceability: The specific standard section (e.g., 5.1.1). Requirement Description: Brief summary of the mandate. Specific measures to mitigate identified risks

34, 18.1, "Training and competency", Training, "Provide training for personnel on software lifecycle processes and tools", "Training records, competency matrix", "Personnel trained and records stored", Not Started, HR, , , Low, "Training and competency"

Map out software items and interfaces.

Verified interaction between software items.