VERAAIQMS Assurance Platform

Welcome to the future of Quality System & Regulatory Compliance

One pass.
Every market.

AI-powered, full-QMS regulatory assurance across every market you sell into, scored against your own documents and explained line by line.

01 The problem

A modern quality system is impossible to verify by hand.

Hundreds of procedures and records, governing thousands of obligations, across every market you sell into. One missed gap becomes a warning letter, a recall, a lost market.

Documents

100+

SOPs, work instructions and records in a typical QMS

Obligations

9,412+

regulatory requirements in a single engagement

Markets

6

each with its own rulebook, plus the ISO/IEC layer

By hand

Weeks to months

of senior time to review it all

02 Coverage

Every market. Every standard.

One pass, reconciled across the markets you sell into and the standards your auditors hold you to.

FDAUnited States

EU MDR / IVDREuropean Union

PMDA · MHLWJapan

Health CanadaCanada

ANVISABrazil

TGAAustralia

Plus MDSAP, and the ISO/IEC standards layered across every jurisdiction.

03 The engine

Verified in hours, not weeks.

Verification overview

Readiness

84

overall QMS score, per jurisdiction

Speed

Hours^*

the full system, not weeks of manual review

Coverage

9,412

obligations scored, quoted not guessed

AI engine

Reasoning

grounded in your own corpus, every call explainable

* About 30 to 60 minutes per regulation, depending on QMS size and scope; a full multi-jurisdiction run completes in hours.

Finding anatomy

04 Every finding

Quoted, not guessed.

Each finding shows the clause it was scored against, the verbatim passage from your own SOP, the risk it carries, and exactly how to close it.

ISO 14971 §10Clause-citedRisk-ranked

05 Grounded in evidence

Four sources behind every call.

No finding stands on the model's word. Each is grounded in the regulation, official guidance, real enforcement history, and your own procedures.

RegulationFDA guidanceForm 483Your SOP

Grounded evidence

Cross-jurisdiction

06 Cross-mapping

Fix it once. Covered in every market.

One requirement is reconciled across both your documents and your markets. If one procedure already covers it, the engine won't raise a false gap in another.

Cross-SOPUS · EU · ISO · Japan · and beyond

07 Your own AI assistant

Ask your QMS anything.

A regulatory assistant that knows your entire quality system. Ask about any clause, SOP, or record and get a grounded, cited answer.

GroundedCitedConversational

AI assistant

Review & sign-off

08 Human verification

AI proposes. Your experts decide.

Nothing is decided by the model alone. Every finding is confirmed or overridden by a reviewer, then signed, counter-signed, and logged.

E-signatureCounter-signedAudit trail

09 Cross-jurisdiction readiness

Inspection & audit ready. Every market.

The whole quality system, scored per jurisdiction, ready for inspection and audit, and explainable.

Engineered to meet BSI's standard for trustworthy AIBS 30440 · ISO/IEC 42001 aligned