Problem Resolution & Anomaly Log (IEC 62304)
€69.00Anomaly and problem-resolution log per IEC 62304 §9 — severity, safety impact, root cause and an auto-calculated summary dashboard.
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Anomaly and problem-resolution log per IEC 62304 §9 — severity, safety impact, root cause and an auto-calculated summary dashboard.

Active Excel traceability matrix linking requirements, architecture, tests, risk controls and anomalies, with auto-calculated coverage summary.

SOUP register and evaluation record per IEC 62304 §8, with CVE screening, safety classification and re-evaluation history. Active Excel workbook.
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