Live traceability
See the relationship between every requirement, control, test, and release.
The AI-native ICDE™
Requirements, controls, and evidence stay in the loop as you build — not reconstructed afterwards.
Every build emits requirements, tests, signatures, and an audit trail an inspector can follow.
From prompt to proof
Explore how Studio keeps product work and compliance evidence connected from the first requirement to release.
Describe the workflow once. Studio structures the requirements, risks, roles, and acceptance criteria before implementation starts.
Build a clinical deviation intake workflow with severity triage, investigation ownership, due dates, and QA approval.
Built for regulated teams
Studio gives product, quality, and engineering teams one shared system of record.
See the relationship between every requirement, control, test, and release.
Run affected checks after every change and know what is safe to release.
Roles, approvals, and immutable history are part of the build—not bolt-ons.
Use a managed Cloud DB with row-level security, policy controls, and exportable records.
Evidence, not screenshots
Traceability is generated as the product changes, giving reviewers a clear path from intended use to verified behavior.
Build the regulated future
Describe what your team needs. RegFoundry Studio will help you define, build, verify, and release it.