Clearance AI helps medical device teams reduce the time spent preparing FDA 510(k) submission materials. Built for regulatory affairs professionals and medical device manufacturers.
Substantial Equivalence: The subject device, Cardiac Monitor CM-200, shares the same intended use as the predicate device K192847 (CardioSense Pro). Both devices are indicated for continuous ECG monitoring in clinical settings... ↳ Cited: 21 CFR 870.2340, FDA Guidance Jan 2024
Regulatory AI needs evidence. Clearance AI is designed so generated outputs can be reviewed against traceable regulatory sources.
Drafts are designed to stay grounded in uploaded evidence, predicate data, and official FDA guidance, with source context available for review.
Requirements are mapped to source ISO clauses or CFR regulations so teams can review the origin of generated text.
A sophisticated drafting tool, not a black box. Professional review and judgment remain the final authority.
From device classification to submission dossier, Clearance AI supports each step with source-backed workflow guidance.
AI identifies your FDA product code, device class, and predicate devices from your description.
Structured gap analysis against ISO standards, FDA special controls, and 510(k) predicates.
Generate 510(k) sections grounded in real regulatory documents with full source citations.
AI outputs are designed to trace back to source documents. Human-in-the-loop by design.
Universal ingestion of FDA guidance, ISO standards, and technical files. Structured entity extraction. Knowledge graph mapping regulatory relationships for 510(k) generation.
Expanding to EU MDR/IVDR technical documentation, CE marking, and FDA De Novo novel classifications.
ISO 13485 quality management, CAPA workflows, design controls, and total post-market surveillance vigilance.
Japan PMDA, Brazil ANVISA, Health Canada, TGA Australia, and automated Clinical Evaluation Report templates.
Clearance AI is a Doxa Studio-built product designed for regulated healthcare workflows.
Doxa Studio builds human-reviewed AI workflow systems for clinics, health organizations, and mission-driven teams.
Clearance AI demonstrates Doxa Studio's approach to source-backed AI, auditability, human review, and practical workflow design for healthcare and regulated teams.
Clearance AI is designed to support regulatory teams. It does not guarantee FDA clearance, regulatory approval, compliance certification, or replace professional regulatory judgment.
Built by Doxa Studio