Threeqa is a QMS and ALM platform built for medical device teams. Designed around IEC 62304, ISO 14971 and ISO 13485 workflows, so your engineers stay on the device.
Replace scattered spreadsheets, doc trees, and side-of-desk Confluence pages with a purpose-built platform that ensures traceability and compliance with the regulations and standards that apply to your device.
Threeqa is built on a graph-on-relational model: every requirement, hazard, design output, test case and risk control is a typed object, and every link between them is a typed, attributed, audited edge. Change one node and downstream impacts are surfaced before you merge.
A risk-based approach grounded in hazard identification, severity × probability matrices, and residual-risk evaluation tied to verification evidence. Not a 200-row spreadsheet.
Documents are assembled from structured data, not copy-pasted into Word. Every approval, redline and superseded version is recorded as an immutable, hash-chained audit event, attributed to a typed actor (user, system, integration or AI). No role, including admin, can edit a signature or delete an audit event.
Re-authenticated signing bound to the exact revision, with a signature meaning the regulator can read. Approval authority is separated from edit authority by design; signatures, once placed, are immutable.
Artifacts are linked, by your team, to the clauses of IEC 62304, ISO 14971, ISO 13485 and MDR they answer to. Regulatory bodies and notified bodies get a coherent story; your team gets a checklist.
Threeqa treats AI as a controlled assistant, never an authority. Every AI suggestion is itself a governed artifact: auditable, attributable, and gated behind a human approval. AI can draft, link and triage, but it can't sign, approve or transition a workflow on its own.
A guided onboarding moves you from spreadsheets to a working setup quickly, with our team alongside you the whole way.
Bring your DHF exports, requirement spreadsheets, and risk files. Threeqa imports them in place, no schema cleanup required.
Link requirements, design, V&V, risk and documents to the clauses of IEC 62304, ISO 14971, ISO 13485 and MDR they answer to. Your team curates; Threeqa keeps every link typed, attributed and audited.
Every missing artifact, broken trace, and unsigned deliverable is surfaced in a prioritized work-down list.
Export a content-hashed evidence bundle for your Medical Device File. DHF in the US, Technical File in the EU. Every export carries per-artifact provenance and a manifest hash your notified body or FDA reviewer can verify, or invite them in directly with read-only access.
Threeqa's workflows are designed around the regulations medical device companies actually face. Your team curates the clause-level mapping that fits your device. Not a generic "compliance" wrapper.
Don't see what you're looking for? We're happy to talk through specifics, including a clause-level review of your existing setup.
Book a 30-minute walkthrough with our team. We'll review where you stand, show Threeqa against your real artifacts, and give you a frank read on what it would take to be certification-ready and get your device cleared for market.