Every requirement, risk, and test —
one living map.
ContextGraf turns your regulated engineering process into a living system of record that stays accurate automatically. Ask what your Design History File looked like on the day of your last submission, and get a real answer — not a spreadsheet reconstruction.
Your traceability matrix is only ever as true as the last person who remembered to update it.
Requirements live in Jira. Risk lives in a spreadsheet. Tests live in Jenkins. Somebody stitches them together by hand before every audit, and the moment anything changes, that picture is already stale.
Ask a regulated engineering team what their Design History File looked like on the day of their last submission. Most can't actually answer that — it's already been overwritten, and nobody kept the receipts.
What's actually built in, not roadmapped.
Eight mechanisms that turn "we have a traceability tool" into "we can prove it, on any date, to anyone."
No AI ever decides who's who
Every requirement, hazard, and test resolves by its real source-system ID, deterministically. AI drafts relationships and language — never identity.
Hash-chained, tamper-evident
Every change is an immutable, cryptographically chained event. An operator with database access still can't rewrite history without breaking the chain.
Ask what was true, on any date
Tag a moment — "510(k) Preliminary Submission" — and revisit it forever. Computed live from real history, never a frozen export.
See the blast radius before you ship
Change one requirement and every downstream hazard, test, and commit is walked automatically — flagged before anyone has to ask.
AI proposes, a human signs
Suggested links, risk drafts, and change judgments sit visibly pending until confirmed — with a 21 CFR Part 11 electronic signature on the terminal decision.
Draft-quality FMEA, not a blank page
Requirements with no risk analysis yet get candidate ISO 14971 failure modes drafted for your risk engineer to review — never auto-filed.
CAPA, non-conformance, complaints — connected
Quality records connect directly to your engineering data, aligned to 21 CFR 820 and ISO 13485 — not a separate system you reconcile by hand.
SRS, SDD, DHF — generated, not assembled
Technical files render on demand, straight from current data, as PDF, Word, or Excel, from any as-of date or tagged milestone.
One trace, start to finish.
Every link in that chain is a fact your existing tools already produce — Jira, Jama, GitHub, Jenkins, Confluence. ContextGraf's connectors normalize each one automatically, so the chain updates itself instead of waiting for someone to notice it's out of date.
Speaks the standards your auditor already speaks.
Today: Life Sciences & MedTech design controls, risk management, and electronic records. The same core engine is architected to extend to EU AI Act, financial controls, and general GRC — without re-platforming.
Not a nicer report. A different source of truth.
See your own traceability matrix, as of any date.
A working walkthrough on your own process — not a slide deck.
Request a walkthrough