Engineered for regulated, safety-critical development
One connected source of truth, requirements through verification — not point tools stitched together with integrations that drift. Change one artifact — even a vulnerable component — and every linked item flags for re-verification, automatically.
AI checks your requirements as you write them — ambiguity, missing criteria, weak verifiability — on a model you bring. It never touches your traceability.
Your own isolated workspace at yourteam.traceunified.com
| Source | TC-220 | TC-221 | TC-222 | TC-223 | TC-224 |
|---|---|---|---|---|---|
| 🔒 REQ-014 Bolus dose accuracy | ✓ | ✓ | ! | ||
| REQ-015 Occlusion alarm latency | ✓ | ✓ | |||
| REQ-016 Battery low warning | ✓ | ✓ | |||
| ⚠ REQ-017 Reservoir volume display | |||||
| 🔒 REQ-018 Basal rate scheduling | ✓ | ✓ | ✓ |
The problem
Requirements in one system, architecture in another, tests in a third, risk and SBOM somewhere else. The trace between them is a spreadsheet someone rebuilds by hand before every audit — and every boundary between two tools is a seam where the thread quietly breaks. The broken link is exactly what an auditor finds.
Each tool owns one link in the chain. None of them owns the whole thread.
The thread
Every artifact is a native record in one database, connected by governed trace links — not synced across tools, not inferred by AI. When an upstream item changes, every downstream link is flagged suspect for re-verification. Try it:
The platform
Each pillar is a real, deep capability — not a thin module. What no point tool can offer is the connection between them: it's the same data, so the thread is intrinsic.
Author, version, and baseline requirements as governed items. Relationship rules define what may link to what, so the trace model is enforced — not left to convention. Optional AI flags ambiguous or untestable language as you write.
Activity diagrams, allocation and satisfy/verify matrices, and model validation — with elements trace-linked to requirements and tests in one database. No ReqIF round-trip, no drifting copies.
Build test plans, execute runs with pass / fail / blocked steps, track milestones, and log defects from failed results — each linked back to the requirement it verifies.
Score risks, link mitigations to requirements and tests, and surface residual risk. When a mitigation changes upstream, the linked risk flags for review.
Import CycloneDX and SPDX bills of materials, reconcile components by package URL, and track vulnerabilities against the components your product actually ships.
See it in action
Intelligence, on your terms
Connect your own model and TraceUnified checks your requirements as you write them. It sharpens the artifacts you own; it never fabricates your traceability. The thread stays deterministic — every link still explicit, human-made, audit-defensible.
OpenAI · Azure OpenAI · Anthropic · your own endpoint
Connected SBOM
The FDA now requires a machine-readable SBOM in premarket submissions for connected devices — and can refuse one that's missing it. But a component list in a separate tool answers nothing when a CVE drops. In TraceUnified every component is a first-class item on the same trace graph as your requirements, risks, and tests — so a vulnerability flags exactly which hazards it threatens and which tests cover it.
1 upstream · 2 downstream · CVE flagged → 1 risk now suspect, re-verification required
Compliance spine
The controls a regulated submission depends on are part of the data model, working across every artifact in the thread — engineered to enable 21 CFR Part 11 compliance.
One spine, configured to the standard you answer to:
Industries
One traceability model, tuned to the standard you answer to. We lead where we're sharpest — medical device — and bring the same spine to every safety-critical domain.
The sharpest fit — design history, V&V traceability, risk, and e-signatures in one record. Demo content ready today.
Objectives traced from requirements through verification.
Functional-safety work products linked across the lifecycle.
Safety functions traced to tests and evidence.
One model from spec to verification.
See it for yourself
Start a free trial and land in your own isolated workspace with a populated, industry-specific project — the whole thread, already linked. Judge it on the work.
yourteam.traceunified.com