26, 12.2, "Record retention", Documentation, "Define retention periods and storage for lifecycle records", "Records retention schedule", "Records retained per regulatory requirements", Not Started, QA, , , Low,
Offers a Requirement Mapping Template to track where each standard section is fulfilled in your documentation. Iec 62304 Checklist Xls
Create a covering all lifecycle activities. 26, 12
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. "Records retention schedule"