Audit prep is broken
Typical cost per external consultant engagement for a single ISO audit cycle
Internal team time spent manually reviewing documents, extracting evidence, and tracking gaps
Of that work is mechanical — matching clauses to documentation and cataloging what's missing
We've been on both sides of the audit table
Aligntra was founded in 2024 by compliance professionals who spent years inside medical device manufacturers, aerospace suppliers, and pharmaceutical firms — building QMS programs, running internal audits, and preparing for external certifications. We also conducted audits evaluating those programs against ISO 13485, AS9100D, FDA QMSR, and EU MDR requirements.
That dual perspective revealed something obvious: the vast majority of audit preparation work is mechanical. Matching requirements to documentation. Extracting evidence. Cataloging gaps clause by clause. Companies were paying consultants tens of thousands of dollars for work that follows a predictable, repeatable pattern. We built Aligntra to automate that pattern — and return findings with exact source evidence so your team can verify every conclusion.
What makes us different
Standards-Native Intelligence
We embed the full authoritative text of every regulatory clause — not keyword summaries. The platform evaluates your documents against what the standard actually says, clause by clause, requirement by requirement.
Every Finding Has a Source
No black boxes. Every gap, every observation, every compliance verdict links to an exact page, paragraph, and quote in your documents. Your team verifies, challenges, and decides what to act on.
Focused, Not Full-Stack
We don't compete with your existing QMS. We specialize in one thing: intelligent gap analysis and audit preparation. This focus lets us go deeper than general-purpose platforms while integrating with whatever you already use.
Built by Auditors
Our team has conducted ISO 13485, AS9100D, and FDA audits. We built the platform to surface what auditors actually flag — not what a generic checklist says might matter.
What we commit to
Traceability First
Every finding cites exact page and paragraph. You verify and decide what to act on. No black box.
Security & Privacy
Documents encrypted in transit and at rest. We never use your data for model training. Enterprise-grade infrastructure.
Transparent Pricing
No hidden fees. No per-user charges on starter plans. You know exactly what you'll pay before you start.
Compliance expertise from both sides of the audit table
Our team has worked inside regulated manufacturers building quality management systems, preparing for certification audits, and managing corrective actions. We've also conducted external audits evaluating those programs against ISO 13485, AS9100D, FDA QMSR, EU MDR, and MDSAP requirements.
That dual perspective is embedded in the platform. Aligntra doesn't just check whether a document mentions a requirement — it evaluates whether the evidence would satisfy an experienced auditor. On the engineering side, our focus is document intelligence: extracting structure from PDFs, linking findings to exact source locations, and making every output verifiable.
Combined experience spanning ISO 13485, AS9100D, FDA QMSR, EU MDR, and MDSAP audit programs across medical device, aerospace, and pharmaceutical industries. Certifications from IRCA, ASQ, and RAB/QSA registrar bodies.
See what an AI-powered gap analysis looks like
Upload a document. Get clause-by-clause findings with evidence in minutes.
Looking to join us? See open positions · Questions? sales@aligntra.com