Your next FDA inspection is retrieval, not creation.

AI-powered audit readiness for small medical device companies. We deploy a compliance system your team runs daily — so evidence is built in, not bolted on.

The problem

Small device companies treat compliance as a final step. Design first, document later, scramble when the auditor arrives. Remediation costs $200K+ and delays launch by months.
The QMSR transition changed how FDA inspects. Disconnected documentation that survived the old approach now fails under risk-based inspection.
Quality consulting is either too expensive ($200–400/hr) or too generic (software with no domain expertise). Companies with 10–50 employees can't afford the first and can't use the second.

What we do

We deploy an AI-powered verification and compliance system configured for your products, your standards, and your tools. Your team runs it daily. Two people with different experience levels produce identical, audit-ready reports.

This is not consulting. It's a working system with 15 years of Class II/III medical device expertise encoded into the rules.

Custom AI agents for your design control activities
Process rules encoded from FDA and ISO standards
Standardized, audit-ready report templates
Integration with your existing tools
Your team trained and running independently after setup

Start with an Audit Readiness Assessment

One week. Five business days. A written report identifying your top compliance gaps, estimated remediation effort, and QMSR readiness.

No commitment beyond the assessment. If the gaps warrant a full deployment, we'll propose it. If not, you have a roadmap your team can execute on its own.

Schedule a conversation

Built on a real program. This framework was developed and validated on an active FDA-regulated Class C medical device program — real requirements, real bugs caught, real audit-ready evidence produced.

Reproducibility validated. Two testers with different experience levels produced structurally identical reports. No consulting firm can claim that.

15 years of domain expertise. Design controls, requirements traceability, risk management, software verification, and FDA pre-submission — encoded as machine-readable rules, not tribal knowledge.