Leading on AI Integration
AuditIQ
AI-assisted audit and compliance, built by a medical device company.
AuditIQ reviews your entire quality management system at machine speed, maps every gap to the FDA QMSR and ISO 13485, and turns weeks of manual audit prep into a prioritized punch list — with our experienced regulatory team reviewing every result.
AI is a powerful part of what we do. It is not all we are.
Plenty of companies bolt “AI” onto a brochure. We built a working tool — and we use it on real engagements. AuditIQ reflects a simple belief: a modern medical device quality practice should put AI to work on the slow, error-prone parts of compliance, so expert humans can spend their time where judgment matters.
But AuditIQ is one capability inside a full-service regulatory and quality firm — not the whole story. Behind it is a team that writes FDA submissions, builds ISO 13485 systems, and runs an FDA-registered operation that gets audited every month. The AI makes us faster and more thorough. The people make devices clear.
What AuditIQ Does
Machine-speed QMS review
Reads your full quality documentation set in a fraction of the time a manual review takes.
Gap mapping
Flags gaps and inconsistencies against ISO 13485 and the FDA QMSR / 21 CFR 820.
Audit-readiness punch list
Prioritizes what to fix before a certification, MDSAP, Notified Body, or FDA inspection.
CAPA & remediation support
Helps triage which records and procedures contributed to a finding, speeding root-cause work.
Where AuditIQ Plugs In
It accelerates the engagements where document review is the bottleneck.
AuditIQ FAQ
What is AuditIQ?
AuditIQ is Boulder RA/QA’s AI-assisted audit and compliance tool. It reviews quality management system documentation at machine speed, surfaces gaps against FDA QSR/QMSR and ISO 13485, and accelerates audit preparation, CAPA, and remediation — with experienced human regulatory professionals reviewing every result.
Does AuditIQ replace a consultant?
No. AuditIQ amplifies a full-service regulatory and quality team. It does the fast, thorough first pass across thousands of pages of documentation; our people apply the judgment that actually gets devices cleared and audits passed. AI is a powerful part of what we do — not all of what we are.
What standards does AuditIQ check against?
AuditIQ maps your documentation against ISO 13485 and the FDA Quality Management System Regulation (QMSR), which takes effect February 2, 2026, as well as the underlying 21 CFR 820 expectations. It is especially useful for QMSR transition gap assessments and pre-audit readiness.
Is my data secure?
We treat your quality documentation as confidential, handled under our quality controls and never shared outside the Boulder BioMed family. For specifics on data handling for your engagement, ask us during your consult.
The Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.