The Smart Compliance List: Everything You Need to Know [Q&A]

Your top questions answered about the future of regulatory tracking

What is the Hoodin Compliance Smart List, and how does it work?

The Smart Compliance List is a purpose-built compliance engine for RA/QA professionals in life sciences. But it’s not just a list generator.

Powered by AI and harmonised regulatory logic, it creates a tailored, living overview of every regulation that applies to your specific product—based on your product type, intended use, materials, markets, and more.

What sets it apart?

• Identifies relevant global, regional, and national regulations

• Reveals local deviations from EU rules

• Tracks transitions and upcoming regulatory changes

• Explains the why behind each requirement

• Receive updates to ensure your compliance stays current with evolving regulations.

What industries or sectors benefit most?

The Smart List is made for life science industries:

• Medical Devices

• In Vitro Diagnostics (IVDs)

• Pharmaceuticals

• Biotechnology

• Digital Health

• Combination Products

If your product is regulated across multiple regions, this tool will save time, reduce risk, and streamline your work.

Can it be customised to our products and markets?

Yes—completely. The Smart List uses your product’s specific attributes (e.g. class, material, intended use) and markets to generate a regulation list tailored to your exact setup.

How does it stay up-to-date?

Hoodin’s AI continuously scans over 600 trusted sources and more than 2,500 regulations and directives globally.

If a regulation is:

• Revised

• Proposed

• Repealed

• Replaced

You’ll see it flagged promptly—along with what changed, when it’s effective, and what to do next.

What are the core features?

✅ Tailored regulation lists based on product data

🌍 Harmonised EU-to-local mapping with deviation alerts

🔁 Always up-to-date tracking with transition flags

🧠 Actionable insights and rationale per regulation

🗂️ Visual grouping by relevance, geography, urgency

How does it minimise compliance risk?

By surfacing changes before they become problems.

You’ll never miss a deadline, overlook a local deviation, or rely on outdated assumptions. It turns regulatory guesswork into verified clarity, helping you prevent audit failures, launch delays, or costly rework.

How is it different from manual tracking?

Spreadsheets, bookmarks, folders, PDFs... they can’t keep up.

The Smart List is:

• Automated

• Structured

• Transparent

  
  

Instead of hunting for what applies, it shows what, why, and what’s new—all in one place.

How is it better than other compliance tools?

Most tools are generic. Hoodin’s Smart Compliance List is built for RA/QA teams in life sciences.

It’s not just a database. It’s a decision tool—with:

• AI-powered mapping

• Clause-level change tracking

• Harmonisation logic

• Global market coverage

• An interface built for action, not just documentation

Can it handle multi-region tracking?

Absolutely. It covers:

• EU, EEA, UK, Switzerland, and candidate countries

• Local implementations linked to EU frameworks

• Deviation detection by country

• Global expansion in progress (North America, Asia, South America)

Is it easy to integrate?

Yes—zero IT integration needed. It fits alongside your QMS or document workflows, offering:

• Compliance summaries

• Regulation lists

• Visual indicators for actions and status

How do you set it up?

Setup is quick and straightforward — just enter key details about your product, confirm what applies, and you’re all set. That’s it — your tailored Smart List is live in minutes.

How quickly will we see value?

Within the first hour. Teams typically go from disjointed tracking tools to structured, real-time regulatory clarity in less than 60 minutes.

How much time does it save?

Most RA/QA users report 70–90% time savings on tracking and list maintenance—freeing up hours for strategy, risk assessment, and audits.

Can it help avoid missed deadlines or costly mistakes?

Yes. You’ll get:

• Up-to-date flags for changes and transitions

• Proactive risk insights

• Clear documentation to keep QMS aligned

No more surprises. No more scrambling.

What’s the long-term value?

It becomes the compliance backbone of your scaling operations:

• Fewer blind spots

• Faster audits

• Stronger internal alignment

• A future-proof process that grows with your products

👉 Want to see how it works? Explore the Smart Compliance List below

Try for Free Here

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