COMING SOON · LAUNCHING IN WEEKS

+ UNPLEX® · REGULATORY BLUEPRINTS

Get a defensible answer.

Unplex® is building Blueprints — browser-based regulatory tools for medical-device teams. Classification, predicates, pathways, fees and timelines, with every output traced to a rule, not an opinion.

Request early access What we're building

The first Blueprints land in the coming weeks — request access and we'll be in touch.

BUILT ON THE RULE-BOOKS YOU WORK WITH

+ WHY UNPLEX®

Regulatory guidance is scattered across gazettes, schedules and PDFs. Unplex® turns it into Blueprints that answer in seconds — and show their work.

01

Decisive

You get the answer — class, predicate, pathway — stated plainly. No "it depends," no candidate list to wade through.

02

Invent nothing

Classifications come only from the official lists; predicates only from approved-device registries. Real rows, never a guess.

03

Traceable end-to-end

Every claim expands to its source — the matched record, the licence number, the rule citation. A defensible audit trail.

+ THE BLUEPRINTS

A library of regulatory Blueprints — across the markets you ship to. Each Blueprint runs in the browser. Each output traces to a rule.

COMING SOONCDSCO MDR 2017

India

Risk class, predicate and the path to licence — fees and timeline included.

COMING SOONUS FDA

United States

Premarket strategy and the road to clearance, mapped to the rule.

COMING SOONEU MDR

European Union

Classification and the conformity route for the EU market.

COMING SOONISO 13485

Quality systems

Quality-system readiness, clause by clause, before the audit.

Building for a market we haven't listed?

Tell us the regulatory decision your team keeps making by hand — it might be the next Blueprint we ship.

Request early access

+ HOW A BLUEPRINT WORKS

From a plain-language description to a determination you can defend.

  1. STEP 01

    Describe the device

    Plain language — what it's for and what it is. No forms to decode, no jargon required.

  2. STEP 02

    Unplex® resolves it

    The Blueprint classifies against the official lists, finds the predicates, and walks the rule-book for you.

  3. STEP 03

    Get a traceable answer

    The route, the requirements, the cost and the timeline — every line expandable to the exact rule behind it.

+ BE FIRST IN

Want a defensible answer the day we launch?

Tell us about your device and the market you're entering. We'll give you early access as the first Blueprints go live.

Request early access