Interactive demo
Click through a live compliance workspace.
A sample project for a steerable catheter: a CAD revision, a supplier change and a firmware release, each traced to the clause it triggers.
Open the blocking event on the dashboardCheck the DHF trackerRead the audit trailResolve the event
Compliance score
84%
↓ 6pts since last sprint
Open items
3
1 blocking release
Events detected
12
Last 7 days
DHF completeness
71%
Risk file outdated
Recent compliance events
Design change detected — catheter tip geometry (CT-1042 Rev C)
1
CT-1042 Rev C released in PDM: tip angle changed from 15° to 22°source: pdm-webhook · 14:32:01
2
Obligation mapped: ISO 13485 §7.3.9 — design change review requiredconfidence: 97% · rule-engine v2.4
3
2 DHF gaps found: risk file not updated · V&V scope not reassesseddhf-scan completed · 14:32:04
4
Action request sent to J. Mehta (QA) — deadline Friday 17:00email dispatched · 14:32:05
5
Design freeze blocked — 2 open items must close firstenforcement-engine · active
6
Audit log pending closureawaiting human sign-off
Supplier change — nitinol wire manufacturer
1
ERP change order CO-291: nitinol wire supplier changed to a new vendorsource: erp-api · yesterday 09:14
2
Obligation: ISO 13485 §7.4 (FDA QMSR) — supplier evaluation required before useconfidence: 91%
3
Supplier audit record not found in QMS — gap flaggedqms-scan · no record found
4
Awaiting supplier qualification submission from procurementreminder sent · due in 3 days
Software version bump — firmware v1.4.2
1
Git tag v1.4.2 pushed — classified as minor version changesource: github-webhook · 3d ago
2
IEC 62304 §6.2 — change classified Safety Class B, maintenance releaseconfidence: 89% · human reviewed
3
No new V&V scope required — existing test coverage confirmed adequate
4
Decision logged with cryptographic hash — audit record created
All compliance events — Steerable Catheter v2.1
Blocking (1)
Pending (2)
Cleared (9)
Detected this sprint
Catheter tip geometry changeJ. Mehta
Supplier change CO-291Procurement
Firmware v1.4.2 bumpCleared
SOP-QA-004 revisionCleared
Sterilisation cycle parameter updateCleared
Regulatory obligations triggered
ISO 13485 §7.3.9
Design change review — open
ISO 13485 §7.4 · FDA QMSR
Supplier qualification — pending
IEC 62304 §6.2
Software change classification — cleared
Design History File — Steerable Catheter v2.1
Design inputs
Complete
Risk file (ISO 14971)
Outdated — update required
Design outputs
Complete
V&V protocols
Scope not reassessed
Traceability matrix
3 unlinked requirements
Design review records
Complete
Open actions
Update risk file: reassess catheter tip geometry change (ISO 14971 §6)J. Mehta · due Fri
Reassess V&V scope for angle change — confirm existing tests cover 22° variantR. Okonkwo · due Fri
Link 3 orphaned requirements to design outputs in traceability matrixS. Patel · due next week
Audit trail — tamper-evident decision log
Decision log
14:32
Design change detected — CT-1042 Rev C
pdm-webhook · hash: a3f9...
14:32
ISO 13485 §7.3.9 applied — change review required
rule-engine v2.4 · conf: 97%
14:32
DHF gap flagged — risk file + V&V scope
dhf-scanner · 2 gaps
14:32
Design freeze blocked — enforcement active
enforcement-engine · state: blocked
09:14
Supplier change detected — CO-291
erp-api · hash: b7c2...
3d ago
Firmware v1.4.2 — cleared by human reviewer
human-review · signed: R. Okonkwo
Confidence scoring — catheter tip event
V&V impact below threshold (80%) — flagged for human review before enforcement
Cryptographic record
event_id: EVT-2026-0418
timestamp: 2026-05-08T14:32:01Z
rule: ISO_13485_7.3.9
confidence: 0.97
hash: a3f9b2c14d8e6f2a91b3c5d7e4f8a2b6
prev: 7c3a1b9f2d4e8a6c...
timestamp: 2026-05-08T14:32:01Z
rule: ISO_13485_7.3.9
confidence: 0.97
hash: a3f9b2c14d8e6f2a91b3c5d7e4f8a2b6
prev: 7c3a1b9f2d4e8a6c...
Stakeholder interactions — system-generated, human-reviewed
Outbound — pending response
To: j.mehta@yourco.comSent 14:32 today
Action required: Risk file update — catheter tip geometry change (CT-1042 Rev C)
Hi Jasprit,
A design change was detected in CT-1042 Rev C (catheter tip angle: 15° → 22°). Under ISO 13485 §7.3.9, the risk file requires review before design freeze can proceed.
Required by: Friday 17:00
Blocking: Design freeze for v2.1
Please update risk file section 6.2 and confirm V&V scope coverage.
— Omni Octa
A design change was detected in CT-1042 Rev C (catheter tip angle: 15° → 22°). Under ISO 13485 §7.3.9, the risk file requires review before design freeze can proceed.
Required by: Friday 17:00
Blocking: Design freeze for v2.1
Please update risk file section 6.2 and confirm V&V scope coverage.
— Omni Octa
Interaction state
Email dispatched to J. Mehta14:32
Reminder queued for Thu 09:00 if no responseAuto
Awaiting response — 2h outstandingOpen
Supplier qual request — CO-291Procurement
Escalation rule: If no response by Thursday 09:00, CC to QA Manager and flag to human reviewer. Design freeze remains blocked.
Event resolved
Sample data for illustration. Names, part numbers and suppliers are fictional.
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