Now Accepting Early Access Applications

Regulatory Clearance
at AI Speed.

Design controls, predicate search, and regulatory research in one platform. PrediClear automates the research and documentation that slows submissions down — so your device gets to market while the window's still open.

Request Early Access See How It Works

Built for biomedical engineers and regulatory professionals who are done with spreadsheet traceability.

prediclear — regulatory intelligence
$ prediclear analyze --device "cardiac-monitor" --market FDA,EU-MDR
Scanning applicable standards: IEC 60601-1, IEC 62304, ISO 14971...
Found 23 predicate devices (510(k) database)
Cross-referencing 847 FDA guidance documents...
Design controls matrix generated: 14 user needs → 38 design inputs
Risk analysis flag: IEC 62366 usability gap detected
Regulatory readiness score: 78% — 4 action items remaining
50%
Faster to regulatory readiness
Fraction
of the cost of legacy QMS platforms
1
Platform for research + traceability
AI-First
Not a document manager with AI bolted on
Platform

Everything Between Concept and Clearance.

Five capabilities that replace the spreadsheet maze, the shared drives, and the $50K/year document management tool.

Market Scope Selector

Choose FDA, EU MDR, Health Canada, or TGA — PrediClear auto-populates every applicable standard, guidance, and pathway. No more hunting through regulatory databases.

Auto-Populates Standards

Design Controls Traceability

A living matrix linking user needs to design inputs, outputs, V&V protocols, and risk controls. Every thread traceable. Every gap visible. Auditors see a system.

Full DHF Traceability

Document Vault

Version-controlled, audit-ready storage organized by project. Every revision tracked. When the auditor asks for version 3 of the risk analysis — you pull it up in seconds.

Versioned & Audit-Ready

AI Product Code Search Engine

Search across FDA 510(k) databases, predicate devices, competitor submissions, published research, and regulatory guidance — all from one query. PrediClear surfaces the predicates that matter, the standards that apply, and the competitive landscape you need to understand. Stop toggling between AccessGUDID, PubMed, and the FDA search portal.

Predicates + Research + Guidance

Adaptive Learning

PrediClear builds institutional knowledge across your projects. It learns your device category, your regulatory history, your risk tolerance — and gets smarter with every submission. When standards change, your projects update automatically.

Learns Your Portfolio
Differentiation

Not Another Document Management Tool.

Legacy QMS platforms were built to store files. PrediClear was built to think about regulatory strategy.

Built for How Regulatory Actually Works.

Existing tools treat regulatory as a filing problem. You upload documents, check boxes, and hope the auditor doesn't ask hard questions. PrediClear treats regulatory as a research and engineering problem — because that's what it is.

  • AI-First Architecture Intelligence is the foundation, not a feature bolted onto a document manager. Every search, every gap analysis, every recommendation is powered by models trained on regulatory data.
  • Research + Traceability in One Platform Competitors separate predicate research from design controls. You end up copy-pasting between tools. PrediClear connects your research directly to your traceability matrix.
  • A Fraction of the Cost Legacy QMS platforms charge enterprise prices for what's essentially versioned file storage. PrediClear delivers more intelligence at a fraction of the cost of legacy QMS platforms.
  • Full-Stack Regulatory Intelligence Predicate search tools exist — but they only search. PrediClear is the full stack: research, design controls, document management, and adaptive learning in one platform.
Legacy QMS Tools
PrediClear
Document storage with manual linking
Auto-generated traceability matrix
Separate tools for research
Integrated AI search engine
Static templates
Adaptive, market-aware standards
$50K+/year enterprise pricing
A fraction of the cost
Manual gap analysis
AI-powered readiness scoring
No learning across projects
Builds institutional knowledge
Community Research

Help Shape PrediClear.

Tell us what's actually slowing you down. Your answers directly influence what we build next — and you'll see how your peers responded once 5+ people weigh in.

Q1 OF 6 — MULTI-SELECT
What is the biggest time-consuming part of designing new medical devices?
Select all that apply.
Step 1 of 6
Q2 OF 6 — MULTI-SELECT
What feature do you wish your current QMS or regulatory tools had?
Select all that apply.
Step 2 of 6
Q3 OF 6 — MULTI-SELECT
Which of these AI capabilities excite you most?
Select all that apply.
Step 3 of 6
Q4 OF 6 — SINGLE SELECT
What do you currently use for design controls and regulatory documentation?
Step 4 of 6
Q5 OF 6 — MULTI-SELECT
Which regulatory markets do you submit to?
Step 5 of 6
Q6 OF 6 — SINGLE SELECT
How soon is your next regulatory submission?
Step 6 of 6
ALMOST DONE
Want to see the results and get early access?

Drop your email and we'll notify you when PrediClear launches. Completely optional — skip to submit anonymously.

Thanks for sharing.

Your responses help us build exactly what the field needs.

Community Pulse

Here's What Your Peers Are Saying

Get to Clearance, Faster.

PrediClear is in early access. Join the waitlist and be first to replace your spreadsheet traceability with AI-powered regulatory intelligence.