From idea to FDA

One path, from “what is my device?” to a submission you can defend.

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.

Describe your device

Tell RAi what it does in plain English, or upload what you have. It builds your device profile and asks only the questions that matter.

Classification

Your likely product code, regulation and device class, with the evidence behind each, so you know which rules apply before you spend on testing.

Predicate

RAi searches cleared 510(k)s, reads their public summaries, and compares each candidate to your device on intended use and technology, with every difference listed.

Full FDA strategy

Pathway, claims wording, the guidance and standards that apply, the testing you need, and whether a Pre-Sub is worth it, in one strategy you approve.

QMS and submission

Design controls, risk management, CAPA and document control under ISO 13485 and 21 CFR 820, linked to your strategy, with a readiness check before you file.

Try the demo

See it think.

Pick a scenario on the left. RAi answers like a senior regulatory consultant, citing the exact regulation, guidance document, or your internal SOP.

RAi · Regulatory Copilot

Reading from 3 connected sources · Last sync 2 min ago

Online

✨ Pick a scenario, or type your own question below

Meet RAi

Your regulatory assistant, on every page.

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.

Ask anything, cited to the reg Takes action in-app You approve before anything is saved

See it work.

Eight features. Click any tab to see RAi in action, the kind of work that used to take weeks of consultant time.

🛡 RAi Guard, Live Pitfall Check

Catches FDA-risky language as you type.

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.

✓"Safe and effective" overclaims, off-label implications, vague quantifiers

✓Each flag links to the exact FDA guidance or CFR section

✓Accept the suggested rewrite with one click, no manual editing

✓Full-document scan gives you a 0–100% submission readiness score

⚠ RAi Guard Pitfall Check

…The device safely and effectively treats is intended to detect chronic venous insufficiency…

⚠ RAi Guard · severity: critical

"Safely and effectively treats" is restricted FDA language. "Treats" also implies a therapeutic indication beyond your cleared diagnostic scope.

Source: FDA OPDP Communications guidance · 21 CFR 801.4

📚 Auto-Citation Engine

Every claim backed by the standard that proves it.

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.

✓Cites from 21 CFR, ISO 14971, IEC 62304, ASTM, USP, and FDA guidances

✓References your own uploaded test reports with page numbers

✓Accept with one click, traceability matrix updates automatically

📚 RAi CiterCitation Suggester

Biocompatibility was demonstrated through cytotoxicity testing on the device contact materials.^{[insert cite]}

📚 RAi found 2 supporting sources (confidence 0.91)

Standard

ISO 10993-5:2009 §8, Test procedures for in vitro cytotoxicity

Your evidence

TR-2024-007.pdf §3.2, Biocompatibility cytotoxicity test report

📊 Submission Tracker

Know exactly where every submission stands.

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.

✓0–100% readiness score per submission section

✓AI Hold countdown with clock-pause during review stops

✓Portfolio Gantt across all submissions for the next 12 months

📊 TrackerSubmission Tracker

Cardiac Stent Mk II · 510(k)

Predicted decision Aug 18, 2026

Pre-SubDraftInternalRTASubst.AI HoldReviewDecision

Submission readiness78%

Top gaps: §13 predicate table · §20 animal study · 2 Guard flags

⚡ AI Document Generation

A complete QMS document in 30 seconds.

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.

✓Quality Manual, Quality Policy, CAPA SOP, Risk File, all generated with AI

✓Opens in editor with RAi Guard running live on the generated text

✓Save to QMS, e-sign Part 11, export as Word or PDF

Quality Manual · Rev 1 · RAi-generated

Quality Manual

CardioWatch CW-300 · Class II · Rev A · Effective June 2026

1. Company Overview

CardioWatch, Inc. designs, develops, and distributes the CardioWatch CW-300 Class II ambulatory cardiac monitor. This Quality Manual describes the Quality Management System maintained by CardioWatch, Inc. in compliance with ISO 13485:2016 and 21 CFR Part 820 (QMSR).

2. Scope

This QMS applies to all activities related to the design, development, and distribution of the CW-300, intended for continuous ambulatory cardiac monitoring in adults aged 22+ with suspected arrhythmia…

🛡 Guard: 0 flags · document looks clean

✅ Regulatory Task Management

Your 510(k) as a project. Every task pre-linked to its regulation.

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.

✓510(k), 17 tasks · CAPA, 10 tasks · QMS Setup, 11 tasks

✓Kanban board: To Do → In Progress → Review → Done

✓My Tasks dashboard widget, all your open work in one place

510(k) Submission Tasks⚡ Auto-generated

In Progress

Biocompatibility per ISO 10993

ISO 10993

Substantial Equiv. Discussion §10

21 CFR 807.87(f)

Done

Confirm predicate device(s)

21 CFR 807.87 · ✓

Draft Device Description §1

21 CFR 807.87(e) · ✓

📅 Portfolio Gantt

Every submission. Every phase. One view.

Phase bars derived from FDA-typical review durations. Decision dates predicted from current stage. AI Hold clock pauses automatically.

📅 Timeline Portfolio Gantt

Submissions across the next 12 months · phase bars are derived from FDA-typical durations + RAi's predicted readiness

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Cardiac Stent Mk II

510(k) · K-pending

Pre-Sub

Drafting

Internal

RTA

Substantive

AI Hold

Subst.

◆ Aug 18

Insulin Delivery Pen v3

De Novo · 41 days in

Drafting (43% ready)

Internal

RTA

Substantive →

AI Triage Algorithm

510(k) + PCCP · 91% ready

Drafting

Internal

RTA

Substantive

◆ Sep 22

Today · Jun 3, 2026

Complete In progress AI Hold · clock paused Upcoming Predicted decision

Plus everything else: threaded comments, version history, electronic signatures bound to a specific document version, RAi-drafted AI-Hold responses, multi-reviewer workflows, project-task Gantt for the work behind each submission, and a live traceability matrix that builds itself as you write.

🧪 Material Builder, ISO 10993-1

Your biocompatibility test matrix in seconds.

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).

✓All 8 ISO 10993-1 contact types, Surface, External Communicating, Implant

✓Transient / Limited / Prolonged / Permanent, cumulative exposure calculator

✓EO, gamma, steam flags, sterilization-specific ISO 10993-7 warnings

✓One-click Biological Evaluation Plan (BEP), saved to your QMS

🧪 Material BuilderISO 10993-1 Matrix

Medical-grade silicone Implant → Tissue/bone Permanent (>30 days)

Required tests: 10 of 12

✓

CytotoxicityISO 10993-5

98%

✓

SensitizationISO 10993-10

97%

✓

ImplantationISO 10993-6

93%

✓

CarcinogenicityISO 10993-3

92%

⚡ RAi AI Agent

Tell RAi what you need. It builds it.

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.

✓Create QMS documents, risk files, SOPs from a single sentence

✓Search predicates, generate task boards, open biocompatibility assessments

✓Every action requires your approval before executing

✓Full audit trail: every agent action logged with timestamp and user

⚡ RAi AgentAction Preview

"Set up my Class II insulin pump project and generate the 510(k) task list"

⚡RAi wants to take 2 actions

Create project “Insulin Pump 510(k)”

Generate 510(k) task list (47 tasks)

One platform

Regulatory, quality, and design control, in one place.

RAi now spans the full medical-device lifecycle: from user needs and requirements traceability to a complete eQMS, AI compliance checks, controlled change management.

🔗

Design Control & Traceability

User needs → requirements → specs → test cases, with a live traceability matrix that flags coverage gaps automatically.

✅

AI Compliance Checker

Point RAi at ISO 13485, ISO 14971, or 21 CFR 820 and get an instant clause-by-clause gap assessment against your QMS.

🔄

Change Control & Red-line

DCR/ECN workflows with attachments, e-signature sign-offs, and side-by-side red-line comparison between any two revisions.

Integrations

Plugs into the tools you already use.

No data migration. RAi reads from your existing systems in seconds.

Or replace them entirely.

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.

See how it works →

OpenAI

✓ Live

Anthropic

✓ Live

Microsoft 365

✓ Live

Google Drive

✓ Live

API / Custom

✓ Available

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.

Plans

Pick the plan that fits where your device is.

Start with your FDA strategy, add your QMS when you need it. Every plan includes cited answers, a private workspace and a tamper-evident audit trail. Book a demo and we will put together a quote for your team.

FDA Guide

For founders getting from an idea to a defensible FDA strategy.

Device profile from a plain-English description or your own documents
Classification: product code, regulation and device class, with the evidence
Predicate search across FDA 510(k) clearances, read and compared to your device
Full FDA strategy: pathway, claims, standards, testing and Pre-Sub plan
RAi Guard, live FDA pitfall detection with one-click rewording
Citation Suggester for 21 CFR, ISO, FDA guidance and your own documents
Submission readiness checks and tracker
FDA deficiency letter analyzer with drafted responses
Core FDA and ISO templates
Priority email support

QMS Suite

Everything in FDA Guide, plus a QMS that holds up to inspection, linked to your strategy.

Everything in FDA Guide
Full QMS: Quality Manual, CAPA, risk management, complaints, internal audits and management review
Design controls with live traceability from user needs to verification
ISO 14971 risk file and FMEA
Change control with e-signature sign-off and red-line comparison
Part 11 e-signatures and a tamper-evident audit trail
Regulatory task boards and a portfolio timeline
Material Builder for the ISO 10993-1 test matrix and your Biological Evaluation Plan
Microsoft 365 and Google Drive connections
AI Agent that drafts documents and tasks for your approval
Dedicated customer success manager

Enterprise

For accelerators, consultancies and device companies with several products.

Everything in QMS Suite
SSO (SAML, Okta, Azure AD), SCIM and advanced roles
Your SOPs, predicates and internal standards indexed
Private deployment options
White-glove implementation and RA/QA data migration
Named customer success manager and uptime SLA
Quarterly regulatory intelligence briefings
Custom payment terms

Pricing depends on your team and how many devices you are bringing to market. No setup fees.

Get your medical device to market faster.

Built for founders taking a medical device to FDA.

One path, from “what is my device?” to a submission you can defend.

See it think.

Your regulatory assistant, on every page.