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Know exactly which regulations apply to your product, why they matter, and how you justify conformity. With a clear foundation for technical documentation you stay audit-ready, even as rules evolve.

One List. Every Regulation. Always up to date.

Smart Compliance List overview

SMART COMPLIANCE LIST

Regulations are evolving.
Is your documentation keeping pace?

Manufacturers today must not only identify applicable regulations but also justify their inclusion or exclusion, validate conformity methods, and maintain structured, auditable evidence. As transition deadlines approach, compliance demands traceability and up-to-date documentation across all relevant legal requirements affecting the product.

Compliance professionals need a system that supports these obligations by ensuring regulatory control and evidence are accurate and audit-ready. Having a reliable foundation to manage applicable laws and conformity justifications is essential for confident compliance and successful audits.

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GAIN REAL-TIME CONTROL OVER APPLICABLE REGULATIONS

Meet the Smart Compliance List

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A structured, automated and traceable system for identifying, monitoring and documenting applicable regulatory requirements – per product, per market, in real time.

  • Gain precision with product and market specific output.

  • Ensure traceability with historic source and version tracking.

  • Take action quickly with structured output for immediate compliance steps.

  • Build credibility through validated and official sources.

  • Increase efficiency by reducing manual labor and compliance risk.

Smart Compliance List interface

Compliance That Works for You

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HARMONISATION

EU regulations aren’t enough

Many countries in Europe apply stricter rules than the EU, while others diverge entirely. The Smart Compliance List makes these local deviations visible from the start, ensuring you can quickly see how each market aligns – or doesn’t – with the EU baseline.

Harmonisation
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TRANSITIONS

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Proactively navigate regulatory transitions

The Smart Compliance List integrates regulatory transition awareness directly into your workflow, flagging outdated rules, highlighting upcoming changes, and providing clear timelines and implications – so you're always ahead of the curve.

Transitions
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UPDATES

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Never miss a revision again

RA teams track hundreds of regulations, but when changes happen – whether it’s a sentence, section, or an entire annex – there’s often no alert. The Smart Compliance List tracks revisions at the clause level, flags changes in real time, and highlights what’s new – ensuring nothing gets missed and nothing slips past your next audit.

Updates

SMART COMPLIANCE

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Hoodin is designed for compliance with major international standards

MDR

Annex ll section 2
Annex ll section 4
Article 10.9
Article 15

IVDR

Annex ll section 2
Annex ll section 4
Article 10.9
Article 15
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You'll be done in just a few minutes!

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Receive a structured and harmonised regulatory overview

The setup only takes a few minutes

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Choose your target markets

Choose where you are - and where you’re headed

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Define your product type and key attributes

Lay the foundation with a few simple inputs

The Smart List is smart 

How it works

Setup

Stop tracking regulations.
Start mastering them.

Finally, a regulatory tool that works as fast and as smart as you do.

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No credit card required

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14-day free trial

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Test ALL features

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