Smart Compliance List now includes North America – What this means for your regulatory strategy
- Team Hoodin
- Jul 16
- 2 min read
We’re excited to announce that as of today, Hoodin’s Smart Compliance List (SCL) has expanded to cover North America – including US federal regulations, all 50 states, and Canada’s national legislation.
This update adds more than 5,000 newly mapped regulations to the platform, on top of the existing 3,000+ European regulations already available. Combined, this gives regulatory and quality teams a single, AI‑powered view of applicable requirements for their products across two of the most complex life science markets in the world.
Why does this matter now?
Regulatory requirements such as FDA 21 CFR 10.9 and MDR Article 10 make it clear: companies must have structured, controlled processes for identifying and understanding applicable regulations. Without this, there is a real risk of missing critical updates, misinterpreting local requirements, or failing inspections.
But manually building and maintaining lists of regulations – especially across federal, state, and national levels – is no longer a sustainable approach.
How Smart Compliance List helps you
Smart Compliance List is designed to solve this challenge. Powered by advanced AI, SCL gives you:
Harmonised bundles of regulations – See how EU regulations, US federal requirements and state‑level laws relate to each other, in one view.
Alignment statuses – Instantly understand where rules are fully aligned, where there are nuances, and where major deviations exist.
Automated monitoring of updates – Stay ahead of changes in US federal regulations and be notified of revisions, amendments and proposals.
Actionable insights for your product – SCL uses your product data to identify applicable regulations and highlight compliance risks.
With North America now included, you can build a complete compliance overview for your products across Europe and North America, confident that nothing critical is overlooked.
Built for regulatory and quality teams
Smart Compliance List is already helping RA and QA teams across Europe to streamline regulatory intelligence and ensure compliance readiness. With this expansion, Hoodin is the first and only platform to deliver the same level of precision and automation for North America.
This means less time spent researching regulations and more time ensuring your compliance strategy is robust – whether you’re launching in one market or managing a portfolio across dozens.
Ready to see it in action?
If you’re an existing Hoodin user, North America coverage is available in your account starting today. Simply add North America to your Smart Compliance List setup to explore applicable regulations for your products.
If you’re not yet using Hoodin, get in touch to see how Smart Compliance List can transform the way you manage regulatory compliance.
