RAi is the regulatory team you do not have yet: classification, predicate, a full FDA strategy, and a QMS that holds up, in one place.
You have a device and a runway, not a regulatory department. RAi tells you what FDA will call your device, which cleared devices to compare it to, what to test, and how to run a compliant QMS, so you spend less on consultants and get to submission sooner.
Each step builds on the one before it. Change an answer and RAi shows you what it changes downstream, so your strategy never drifts from your device.
Pick a scenario on the left. RAi answers like a senior regulatory consultant, citing the exact regulation, guidance document, or your internal SOP.
RAi follows you through the whole platform. Ask a question or just tell it what you need, draft an SOP, open a CAPA, check what's missing for your 510(k), and it does the work right where you are, then hands you the result to approve. No context-switching, no new tab.
Eight features. Click any tab to see RAi in action, the kind of work that used to take weeks of consultant time.
Every paragraph is scanned against 39 FDA pitfall patterns in real time. Each flag shows the exact CFR citation, explains why it's risky, and offers a one-click rewrite.
…The device safely and effectively treats is intended to detect chronic venous insufficiency…
Select any sentence and RAi finds the exact 21 CFR section, ISO clause, or FDA guidance document that supports it, plus citations from your own uploaded test reports and SOPs.
Biocompatibility was demonstrated through cytotoxicity testing on the device contact materials.[insert cite]
Live phase tracker from Pre-Sub through decision. Readiness score per section. AI Hold clock pauses automatically. Predicted decision date calculated from current stage and FDA-typical durations.
Click "Generate Quality Manual" and RAi writes a complete, organization-specific document using your device name, intended use, and device class. Every your device details filled. Fully editable.
One click generates a complete task board for any workflow. Every task includes its regulatory requirement, due date, and assignee, no more missing steps or forgotten CFR sections.
Phase bars derived from FDA-typical review durations. Decision dates predicted from current stage. AI Hold clock pauses automatically.
Enter your device material, body contact type, and duration. RAi maps ISO 10993-1's full test matrix, scores the likelihood of passing each test based on published 510(k) precedent, flags sterilization risks, and generates your Biological Evaluation Plan (BEP).
RAi's chat is not just answers. It's an agent that takes actions across the platform. Ask it to create a document, run a predicate search, or generate a task list. It shows you an approval card and executes on confirm.
RAi now spans the full medical-device lifecycle: from user needs and requirements traceability to a complete eQMS, AI compliance checks, controlled change management.
No data migration. RAi reads from your existing systems in seconds.
RAi includes a full QMS, document management, submission tracker, task board, CAPA system, and audit trail, built in. Many teams use RAi as their complete regulatory stack, not just an add-on.
Connect any MCP-capable AI client with one URL. More document sources are in development; we list an integration here only once it is live.
20 minutes. We'll show RAi working on a submission like yours.
Bring RAi to your cohort. We'll set up portfolio credits and a regulatory onboarding track for your startups.
Document upload, gap analysis, RAi Guard pitfall check, and Citation Suggester live inside the RAi app. The public chat is text-only.
