Map user needs through system requirements, design inputs/outputs, test methods, and acceptance criteria — with regulatory clause traceability, phase tracking, and trace-health scoring for FDA 21 CFR Part 820.30 and ISO 13485 design control
FDA 21 CFR Part 820ISO 13485ISO 14971IEC 60601-1IEC 62366IEC 62304Auto-saved
Trace flow: requirements are the source IDs. Add REQ-xxx, DV-xxx, TP-xxx, or FM/UR/PF-xxx references in fields to create badges that open the related planning tool with that ID pre-filtered.
User Need→
System Requirement→
Design Input→
Design Output→
Test Method→
Acceptance Criteria→
Result
Trace matrix
EARS pattern:While <state>, when <trigger>, the <system> shall <action> (within <measurable limit>).
Use it in the System Requirement column for unambiguous, testable wording (Mavin et al., 2009).