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IEC 62304 Draft: Verification and Traceability Matrix

Document Control

  • Product: Onset iOS
  • Version baseline: 1.2.6 (build 1)
  • Status: Draft for FDA workstream kickoff

Matrix

Requirement ID Verification Method Evidence Artifact Status
SR-001 Build + runtime config review FeatureFlags.swift values and release checklist output Initial pass
SR-002 UI inspection + code search Today/Protocol/Scanner interaction surfaces gated by advisoryCopy Initial pass
SR-003 Code path verification ProtocolEngine check-in modifier block behind adaptiveProtocol Initial pass
SR-004 UI and engine path review Lab interpretation surfaces hidden/disabled by labInterpretation Pending expanded test
SR-005 Metadata + in-app legal copy review App Store submission guide + disclaimer surfaces Initial pass
FR-101 Functional test (journal save) Daily Journal save flow and persisted values Initial pass
FR-102 Functional test (no adaptive output claim) "Journal entry saved" confirmation behavior Initial pass
FR-103 Functional test (Trends data-only) Chart-only trends with averages, no recommendations Initial pass
FR-104 Functional test (completion tracking) Routine completion toggles and persistence Initial pass
FR-105 Notification text review Neutral reminder strings in notification manager Initial pass
NFR-301 Compile check xcodebuild build success logs Initial pass
NFR-302 Language audit grep No flagged terms in .swift copy search Initial pass
NFR-303 Project file audit MARKETING_VERSION=1.2.6, CURRENT_PROJECT_VERSION=1 across targets Initial pass
NFR-304 Smoke test Journal/trends/notifications runtime behavior Pending device run

Planned Expansion for FDA Track

  • Add protocol-level test IDs and expected outcomes for each gated branch.
  • Add hazard linkage columns (Hazard ID, Risk Control ID, Residual Risk).
  • Attach evidence snapshots (screens, logs, test reports) per requirement.