Hoodin has made regulatory compliance easier for us, turning complex tasks into simple processes
Lai Wun Lau
Regulatory Affairs Professional, United Kingdom
Hoodin is fun to use! The AI assistance does the majority of the work. All I had to do was answer a few simple questions, and the customisations were easy to make.
Molly Procopio
Medical Device Expert, USA
Hoodin has the potential to outperform all other platforms available to facilitate regulatory professionals in their daily work.
Mayank Marvania
Regulatory Consultant, India
SMART COMPLIANCE
8,000+ regulations covered.
Designed to build your applicable list.
Hoodin monitors over 5,000 regulations in North America and 3,000+ in Europe — spanning medical devices, IVDs, pharma, biotech and all required cross-domain frameworks such as GDPR, REACH, RoHS, AI Act and any regulation that may be applicable for your product or company.
From this coverage, the system generates a justified list of applicable regulations — per product, per market — audit-ready and continuously updated.
SMART COMPLIANCE
Gain Real-time control over applicable regulations
Hoodin automates the identification, justification and maintenance of applicable regulations — per product, per market. Structured, traceable and audit-ready by design, with continuous monitoring to ensure you never miss what matters.
Manual lists are no-good for compliance. But very good at putting you at risk.
Spreadsheets and static documents can’t satisfy Annex II, Section 4, Article 10.9 or FDA 21 CFR. They lack justification, traceability and structure — and they leave you exposed to findings, delays and compliance gaps.
FOR LIFE SCIENCE RA/QA PROFESSIONALS
Your Regulatory Intelligence Tool for Audit-Ready Compliance
Built for life sciences teams to identify, justify and maintain applicable regulations — delivering audit-ready, traceable compliance and continuous updates.
With Hoodin, you create and maintain your justified list of applicable regulations. AI-supported, audit-ready, and aligned with:
Annex II, Section 4 MDR/IVDR
Article 10.9 MDR/IVDR
ISO 13485 §4.1.3
FDA 21 CFR Part 820 (QMSR)
Notified Body Expectations
Frequently Asked Questions
Find answers to common questions about who can benefit from Hoodin and what it costs. Get the essential details to see if Hoodin is the right fit for you. Don't hesitate to contact us if you can't find the answers you're looking for.
Check out our price list here.
Hoodin is designed for a wide range of life sciences products, including medical devices, IVD, SaMD, Combination products, pharmaceuticals and biotechnology innovations.
Yes, we offer a free trial period of 14 days for new users to experience Hoodin’s capabilities firsthand before committing to a subscription.
We offer a streamlined onboarding process. You can expect to start seeing initial results within a few days of setting up your project. Expect to set aside 30 minutes to set up your first hub and then we recommend 2 time 30 minuts more to investigate the results and try out various features. We strongly recommend that every trial period shall include a video meeting with one of our experts to secure that you get the best out of Hoodin. Contact us to book a time slot.
Annex II (Section 4) requires a documented and justified list of applicable regulations. Hoodin automatically generates this list with full traceability and export options, so it can be included directly in your technical documentation.
Yes. Article 10.9 requires manufacturers to implement and maintain a system for staying up to date with applicable regulations. Hoodin continuously monitors validated sources, notifies you of changes, and links them to your applicable regulations list — ensuring you can demonstrate compliance with Article 10.9 at all times.
FDA 21 CFR 820 requires manufacturers to control applicable requirements within their quality system. Hoodin identifies the relevant regulations and tracks changes over time, creating an audit-ready record that can be integrated into your existing QMS processes.
Yes. Hoodin creates a structured and traceable list of applicable regulations in line with Annex II (Section 4) and Article 10.9 MDR/IVDR. The list can be exported and used directly in technical documentation or during audit preparations.
Hoodin monitors only validated sources, such as regulatory authorities, standardisation bodies and official registers. All sources are documented and directly linked, so you can always verify the information.
Yes. All updates are connected to your applicable regulations list. With AI support, you receive guidance on potential implications and scenarios, helping you identify what matters most for your specific product and markets.
Hoodin is developed in line with ISO 13485:2016 §4.1.6 and GAMP 5 principles. The platform undergoes continuous verification and testing, and full release documentation is available. Each customer is responsible for performing system validation within their own QMS, but Hoodin provides the necessary documentation to support that process.
