Every design input linked to its outputs, verification and validation. Every software unit traced to a requirement. Technical files assembled from the evidence you already have. Agents draft. Your quality and regulatory team signs.
Notified bodies and FDA reviewers do not test your device. They test your evidence. And the evidence chain breaks in the same four places.
A requirements spec full of “shall” statements nobody numbered or linked.
ISO 14971 controls with no verification record behind them.
IEC 62304 unit-to-requirement trace rebuilt by hand before every release.
The missing link is found by the notified body, months before launch.
Qualitum keeps the chain intact - as data, not documents.
What the engine reads, links and drafts. Every item keeps a link to the requirement it answers.
Coverage is measured against the clause, not against a template.
Procurement, biomedical engineering and quality teams accepting devices and components.
Design, quality and regulatory teams at device makers and contract manufacturers.
Same engine that runs pharma validation, applied to design controls.
Requirements, risk file, test reports and software docs, from your ALM, eQMS or folders.
Inputs, outputs, risks and tests become linked records with IDs.
Untested inputs, unverified risk controls and broken software trace, each flagged.
Protocols, trace matrices and file sections drafted. Your team reviews and signs.
We trace each design input to the verification evidence you sent and list what is missing, partial or contradictory.
Our reference deployment is in pharmaceutical validation. Screens on this page show illustrative examples, not customer data.
No. Keep Jama, Polarion, Greenlight or your eQMS. Qualitum reads from them, checks coverage against evidence and writes results back for review.
Yes. Software requirements, architecture items, units and tests become linked records, and missing links are flagged on every change.
No. Agents draft and check. Your qualified people review, approve and sign every output.
In a single-tenant deployment inside your environment, with your choice of model, EU, US or UAE residency and air-gap capability. No training on your data.