AI-Powered Regulatory Compliance for Medical Device Companies

FDA QMSR · ISO 13485 · EU MDR audit-ready in days, not months.

Request Invite Watch Demo
11
Model AI Council

OpenAI · Anthropic · Google · Perplexity SOTA models analyze every regulatory question in parallel.

FDA-Investigator Simulations

Practice audits with scored debriefs. Find weaknesses before the real inspection ever happens.

224
Warning Letters Analyzed

1152+ deficiencies mapped to QMSR/ISO 13485 clauses, refreshed daily from FDA.

Everything a QMS leader needs

Seven integrated tools that turn regulatory work from reactive scrambles into a predictable cadence.

Audit Coach

Practice FDA-style and ISO inspections with an AI investigator. Multi-turn questioning, scored debriefs, and targeted weakness reports help you train your team safely between real audits.

Gap Analysis

Upload procedures across 28 QMS document types and get a 0–100% readiness score against QMSR. AI identifies missing clauses, suggests remediation, and exports a board-ready PDF.

Council Mode NEW

Eleven SOTA models stream answers in parallel — OpenAI, Anthropic, Google, Perplexity. Compare specialist perspectives, see consensus metrics, and ground decisions in cited sources.

Warning Letter Insights

Every FDA medical-device warning letter, automatically fetched daily, with deficiencies mapped to 21 CFR / QMSR / ISO 13485 clauses. Spot enforcement trends before they hit you.

CAPA Management

Generate, track, and close corrective actions with a full audit trail and 21 CFR Part 11 dual-control approval workflow. Cross-link CAPAs to FMEA risks and source warning letters.

QMS OS Agent Beta

Supervised autonomous CAPA investigations. The agent drafts root-cause analyses and remediation plans; you review and approve every action via a one-click human gate.

FMEA Worksheet NEW

ISO 14971-aligned with AI-suggested failure modes from a 3-model council. Color-coded RPN matrix, CAPA cross-links, PDF/Excel export, and append-only audit history for traceability.

From the field

Sample pilot quotes — request access for full case studies.

"Sample Pilot Quote — request access for full case studies. Cut our internal audit prep from three weeks to four days while improving finding quality."

— VP Quality, Class II diagnostics startup

"Sample Pilot Quote — request access for full case studies. The Council Mode lets me see when the models actually disagree, which is when I need to dig deeper."

— Director Regulatory Affairs, surgical robotics OEM

"Sample Pilot Quote — request access for full case studies. Warning Letter Insights surfaced a 21 CFR 820.100 trend that reframed our CAPA backlog."

— Head of Compliance, orthopedic implant manufacturer

As featured in: LinkedIn · FDA Town Hall · Skool community

Simple pricing

Invite-only beta. Apply for access — paid tiers unlock as you grow.

Free
$0/mo
  • Audit Coach (3 sims/mo)
  • Warning Letter Browser
  • 3 FMEAs / 20 items
  • Single user
Pro Most popular
$49/mo
  • Unlimited audit simulations
  • Gap Analysis (28 doc types)
  • Council Mode (11 models)
  • Unlimited FMEA + CAPA
  • QMS OS Agent (Beta)
  • PDF / Excel exports
Request Invite
Enterprise
Contact
  • Everything in Pro
  • SSO + audit-trail export
  • Custom regulatory frameworks
  • Dedicated CSM
  • Priority support SLA
Contact Sales