01Flagship · Regulatory automation
Cloqi Doss
/kloʊ.ki dɒs/A product-operations workspace that structures repetitive regulatory, review, and traceability work for medical-device software.
The starting question
How can complex regulatory work become more accurate, traceable, and repeatable?
Cloqi Doss grew from first-hand experience leading RA/QA work at a SaMD and digital-health startup, including a rewrite of the quality manual. It connects product versions, intended use, evidence, decisions, and commitments across product, RA/QA, engineering, clinical, and commercial teams. The customer's external QMS remains the official system of record; AI output remains a candidate until a person reviews and adopts it.
Hédéonix role
- Problem framing
- Domain architecture
- Product design