■ Medical Device & IVD
Meet the regulatory clock without scaling headcount.
Medical device companies operate under some of the most demanding regulatory and commercial constraints in the market. We deploy senior advisors to remove those constraints across revenue, finance, and technology.
■ Lead Use Case
The PMS Co-Pilot.
Process thousands of complaint records, detect safety signals, and draft PSUR narratives with a human-in-the-loop system. Our engineering team has a track record of reducing regulated medical workflows from hours to minutes.
- Automated intake, coding, and causality assessment support.
- DHF Traceability Engine integration.
- Deployed on-premise to meet strict security and validation requirements.
■ The Regulatory Context
QMSR is enforceable. The documentation burden is real.
The FDA Quality Management System Regulation is now in effect. EU AI Act provisions are landing. Organizations that cannot demonstrate a validated, traceable documentation process face real regulatory exposure.
- Human-in-the-loop design to fit validation processes.
- Cited, grounded answers for regulatory explainability.
- Full audit logging for FDA and notified body review.
Ready to see if there is a fit?
Tell us what you are working with. A real person will read it and reply within one business day.
Start a Conversation