| Column A | Column B | |----------|----------| | Safety Class | A, B, C (based on possible harm) | | Clause Ref | IEC 62304 clause number | | Required | Yes / No / Conditional | | Verification | Not started / In progress / Done / N/A |
39, 22.1, "End-of-life planning", Maintenance, "Define software end-of-life and transition plans", "EOL policy, customer notifications plan", "EOL criteria and communication defined", Not Started, Product Manager, , , Low, Iec 62304 Checklist Xls
Establish procedures for evaluating problem reports and assessing the impact of changes on safety. | Column A | Column B | |----------|----------|
Sarah started her XLS sheet by categorizing their software. She knew that the level of rigor required depended on the potential for harm. : No injury possible. : Non-serious injury possible. : Death or serious injury possible. The Story Note : No injury possible
29, 14.2, "Vulnerability management", Security, "Process to identify, track and remediate security vulnerabilities", "Vulnerability log, patch management process", "Vulnerabilities assessed and remediated", Not Started, Security Team, , , High,