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Is your product a medical device?

We help founders find out where they stand. Answer a few questions to see your device class, the frameworks that apply, and your next steps.

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Captain Reg - Personal Assistant

A good product description should cover:

•

What it does - in plain language, the core function (e.g. “provides personalised recipes and meal plans”)

•

Who uses it - patients, clinicians, carers, or a mix

•

The health problem it addresses - IBS and digestive issues, in your case

•

What it involves - is it an app, website, software only, or does it include hardware or AI?

•

What it does NOT do - e.g. “does not diagnose IBS” or “does not replace medical advice”

For a recipes app, you’ll want to be clear about whether it’s purely informational (curated content for self-management) or whether it analysed user data, made personalised recommendations based on symptoms, etc. That distinction matters for classification.

Keep it to 3-4 sentences and write it straight into the box on the left whenever you’re ready. I’m here if you get stuck.

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Classification

Classify your product and understand its regulatory position — with the reasoning shown at every step, so you know why, not just what.

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Inconsistencies

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Monthly

Annually

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Product classification

Market access strategy, timelines & cost

Intended use & product description

Inconsistency checks

Captain Reg, your 24/7 AI assistant

Pro

From £200

/ month

For growing teams who are ready to automate at scale.

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Everything in starter

Pre-built ISO templates with automation

NHS specific frameworks

Priority support

Enterprise

Custom

For innovation network and accelerator

Book a call with us

Regulatory support at scale

Dedicate account manager

Quarterly reporting and analytics

Monthly

Annually

Starter

£70

/ month

For funded startups pursuing certification.

Get started

Product classification

Market access strategy, timelines & cost

Intended use & product description

Inconsistency checks

Captain Reg, your 24/7 AI assistant

Pro

From £200

/ month

For growing teams who are ready to automate at scale.

Get started

Everything in starter

Pre-built ISO templates with automation

NHS specific frameworks

Priority support

Enterprise

Custom

For innovation network and accelerator

Book a call with us

Regulatory support at scale

Dedicate account manager

Quarterly reporting and analytics