RAi stands for Regulatory Affairs Intelligence (pronounced "ray"). RAi drafts your 510(k), De Novo, PMA, and IND sections; catches FDA-risky language as you write; auto-cites every claim from your standards library and your own evidence; and tracks every submission through the FDA review lifecycle. A Clemtech Medical Solutions product.
Pick a scenario on the left. RAi answers like a senior regulatory consultant — citing the exact regulation, guidance document, or your internal SOP.
RAi is a real co-author, not a chatbot. It writes alongside you, watches for FDA pitfalls, traces every claim back to evidence, and shows you exactly where your submission stands.
Drafts your 510(k), De Novo, PMA, IND, NDA, and BLA sections from your evidence — your test reports, SOPs, predicate K-numbers, and design history. Every paragraph is yours to accept, reword, or reject.
Catches FDA-risky language as you type. "Safe and effective" claims without evidence. Off-label implications. Vague timing. PCCP overreach. Each flag includes the FDA citation and a suggested rewording — accept it with one click.
Drag a fact into the doc and RAi finds the standard that supports it — 21 CFR, ISO 14971, IEC 62304, ASTM, USP — plus your own test reports and SOPs. Accept the cite and the design controls traceability matrix updates automatically.
Live progress bar through every FDA phase. Pre-Sub, RTA, substantive review, AI Hold (with clock pause), decision. Readiness score per section. Predicted decision date. The dashboard your CEO and board have been asking for.
Aligned with the FDA Quality Management System Regulation (QMSR) — the new regulation harmonizing 21 CFR 820 with ISO 13485:2016, effective Feb 2, 2026. Don't have a QMS yet? RAi builds one for you. Have Greenlight Guru, MasterControl, or Veeva? RAi reads from them and writes back. Either way you're audit-ready.
Hash-chained audit log — change one row and the chain breaks visibly, so an inspector can verify integrity in seconds. 21 CFR Part 11 §11.50 electronic signatures bound to a specific document version. Every accept, reject, comment, approval, and login logged with user, timestamp, and reason. Export to a signed PDF for FDA inspection.
Three moments from inside the app. The kind of work an RA/QA team used to outsource to consultants for $20–50K per submission — happening live, in the document, in seconds.
…The device safely and effectively treats is intended to detect chronic venous insufficiency…
Biocompatibility was demonstrated through cytotoxicity testing on the device contact materials.[insert cite]
No data migration. RAi reads from your existing systems in seconds.
Monthly or annual billing — annual saves 16% (two months free). Enterprise is annual-only and includes implementation services. 14-day free trial on FDA Guide and QMS Suite.
The AI regulatory consultant. For solo founders, RA consultants, and small teams who need cited answers fast.
The real product. Everything in FDA Guide, plus the full RAi editor with Guard, Citation Suggester, Submission Tracker, Portfolio Gantt, e-signatures, and a 21 CFR 820.30 QMS — built from scratch or layered over your existing one.
For consultancies, mid-to-large medical device companies, pharma, and multi-product portfolios. Annual contracts only.
All plans include cited answers, tamper-evident audit logs, and SOC 2 Type II security. Usage credits cover AI consultation, document analysis, embedding, and template generation. Overage rate $0.50 per credit. Annual contracts save 16% (2 months free). No setup fees.
Get a personalized walkthrough with one of our regulatory specialists. We'll show you RAi on your own SOPs and submissions, under NDA.
20 minutes. We'll show RAi working on a submission like yours.