Iec 62304 Checklist Xls _verified_ [ Authentic ]

Define roles, responsibilities, and external system interfaces. 2. Software Requirements Analysis (Clause 5.2)

Document a process for investigating and resolving anomalies. Software Safety Classifications Iec 62304 Checklist Xls

As the product neared completion, the "Verification" tab became the team's daily dashboard. Unit Testing : Did the individual code blocks work? Integration Testing : Did the blocks work together? System Testing : Did the whole device meet the original requirements? The "Green" Moment : Every time a test passed, Sarah turned the cell Sarah turned the cell 14

14, 7.2, "Problem resolution and tracking", Maintenance, "Record, investigate, and resolve software anomalies", "Issue tracking system, CAPA records", "All issues logged and dispositioned", Not Started, Support Lead, , , Medium, "Problem resolution and tracking"