The AI platform FDA-regulated companies run on.

RAi isn't a chatbot. It's a full regulatory co-author — drafting submissions, catching risky language in real time, auto-citing every claim from your evidence, and keeping your QMS audit-ready. Built by regulatory consultants who got tired of doing the same work manually.

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AI Co-Author

Drafts your 510(k), De Novo, PMA, IND, NDA, and BLA sections from your evidence. Every paragraph is yours to accept, reword, or reject. One click fills every [PLACEHOLDER] with your device details.

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RAi Guard — Live Pitfall Check

Catches FDA-risky language as you type — "safe and effective" overclaims, off-label implications, vague quantifiers. Each flag shows the exact CFR citation and a suggested one-click rewrite.

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Auto-Citation Engine

Select any claim and RAi finds the exact 21 CFR section, ISO standard, or FDA guidance that supports it. Citation inserted inline. Design controls traceability matrix updates automatically.

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Regulatory Task Management

Built-in Asana-style task boards for every project. Auto-generates a complete task list for 510(k) submissions (17 tasks), CAPAs (10 tasks), QMS setup (11 tasks), and EU MDR — each task pre-linked to its regulatory requirement.

📋

AI-Generated QMS

Click "Generate Quality Manual" and RAi writes a complete, organization-specific QMS document using your device name, intended use, and device class. ISO 13485 §4.2.2 compliant out of the box.

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CAPA + Risk Management

Open a CAPA and RAi conducts a 5-Why root cause analysis, drafts the corrective action plan, and auto-creates verification tasks. ISO 14971 risk files generated with full hazard tables.

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510(k) Readiness Checklist

18-section interactive checklist with AI scoring per section. See exactly what's missing, what's complete, and what FDA will flag. "Draft →" on every section opens the AI co-author pre-loaded.

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Semantic Predicate Finder

Vector search across the entire FDA 510(k) clearance database. Finds predicates by meaning, not just keywords — catches similar devices described with different terminology.

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Part 11 Audit Trail

Hash-chained audit log. Every action — edit, AI score, approval, e-signature — logged with user identity, timestamp, and document hash. Tamper-evident. Inspector-ready. Export to PDF in one click.

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 [PLACEHOLDER] 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

Clemtech Medical, LLC designs, develops, and distributes the CardioWatch CW-300 Class II ambulatory cardiac monitor. This Quality Manual describes the Quality Management System maintained by Clemtech Medical 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)

Simple pricing. Built for teams of every size.

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.

FDA Guide

$2,500/month

For solo founders, RA consultants, and small teams focused on getting submissions across the finish line.

1 user included (+$400/mo per extra)
AI Co-Author — drafts 510(k), De Novo, PMA, IND, NDA, BLA sections from your evidence
RAi Guard — live FDA pitfall detection + one-click rewordings
Citation Suggester — auto-cites every claim from 21 CFR, ISO, FDA guidance + your own docs
Predicate Finder — semantic search across all FDA 510(k) clearances
510(k) Readiness Checklist — 18-section tracker with AI scoring per section
FDA Deficiency Letter Analyzer — paste any FDA letter, get drafted responses
Submission Tracker — live phase tracker + readiness scoring
5 core FDA & ISO templates
500 usage credits/mo
Priority email support

Try the demo first →

QMS Suite

$5,500/month

The full regulatory operating system. Everything in FDA Guide, plus your complete QMS infrastructure, team task management, and audit-ready document control.

Everything in FDA Guide
3 users included (+$400/mo per extra)
Full QMS — Quality Manual, Quality Policy, CAPA, Risk Management, Complaints/MDR, Internal Audits, Management Review (AI-generated, fully editable)
Regulatory Task Management — kanban boards, auto-generated task lists for 510(k), CAPA, audit prep, EU MDR (each task pre-linked to its CFR citation)
Portfolio Gantt — all submissions across the next 12 months with predicted decision dates
25+ FDA & ISO 13485 templates — Design Plan, DVP, FMEA, DHF, Risk file, SOPs
ISO 14971 Risk File generator — full hazard table with probability/severity matrix
CAPA root cause AI — 5-Why analysis, corrective action plan, effectiveness tracking
Part 11 e-signatures + tamper-evident hash-chained audit trail
Connect Egnyte, SharePoint, Greenlight Guru, MasterControl, Veeva
Material Builder — ISO 10993-1 biocompatibility test matrix + BEP generator
AI Agent — chat that creates documents, tasks, and assessments on approval
1,500 usage credits/mo
Dedicated Customer Success Manager

Try the demo first →

Enterprise

From $15,000/month

For mid-to-large device companies, pharma, and consultancies managing multi-product portfolios. Annual contracts only.

10 users included (+$300/mo per extra)
Everything in QMS Suite
Private deployment / dedicated VPC
SSO (SAML / Okta / Azure AD) + SCIM + advanced RBAC
Custom regulatory corpus — your SOPs, predicates, internal standards indexed
Custom usage credit volume + dedicated inference capacity
White-glove implementation + RA/QA data migration
Named Customer Success Manager + 99.9% uptime SLA
Quarterly regulatory intelligence briefings
Material Builder + AI Agent — all features, unlimited usage
Annual contract — custom payment terms available

Try the demo first →

All plans include cited answers and tamper-evident audit logs. 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.

RAi — the regulatory OS for FDA-regulated companies.

See it think.

RAi is doing the regulatory work

The AI platform FDA-regulated companies run on.

AI Co-Author

RAi Guard — Live Pitfall Check

Auto-Citation Engine

Regulatory Task Management

AI-Generated QMS

CAPA + Risk Management

510(k) Readiness Checklist

Semantic Predicate Finder

Part 11 Audit Trail

See it work.

Catches FDA-risky language as you type.

Every claim backed by the standard that proves it.

Know exactly where every submission stands.

A complete QMS document in 30 seconds.

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

Every submission. Every phase. One view.

Your biocompatibility test matrix in seconds.

Tell RAi what you need. It builds it.

Plugs into the tools you already use.

Simple pricing. Built for teams of every size.

FDA Guide

QMS Suite

Enterprise

Cut submission prep time by 60%.

See it think.

RAi is doing the regulatory work

The AI platform FDA-regulated companies run on.

AI Co-Author

RAi Guard — Live Pitfall Check

Auto-Citation Engine

Regulatory Task Management

AI-Generated QMS

CAPA + Risk Management

510(k) Readiness Checklist

Semantic Predicate Finder

Part 11 Audit Trail

See it work.

Catches FDA-risky language as you type.

Every claim backed by the standard that proves it.

Know exactly where every submission stands.

A complete QMS document in 30 seconds.

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

Every submission. Every phase. One view.

Your biocompatibility test matrix in seconds.

Tell RAi what you need. It builds it.

Plugs into the tools you already use.

Simple pricing. Built for teams of every size.

FDA Guide

QMS Suite

Enterprise

Cut submission prep time by 60%.

Book your demo

Got it — talk soon.

Upload your draft — let RAi review it