ABOUT HOODIN
Built for Regulatory Control.
Backed by Domain Expertise.
Who we are
We’re compliance technologists with a passion for solving regulatory complexity — and we’ve seen first-hand how outdated tools hold teams back.
Hoodin was founded in Sweden and has spent over a decade developing intelligent monitoring and compliance technology for life sciences.
Our mission is clear:
Help regulatory teams stay in control, reduce risk, and meet global compliance demands without drowning in manual work.
The challenge
Hoodin exists to solve one of the most fundamental challenges in life science compliance:
How do you know and prove what regulations apply to your product, today?
We built Hoodin to help RA/QA professionals gain control over regulatory complexity. With AI-supported automation, Hoodin enables you to create and maintain an auditable, justified, and always up-to-date list of applicable regulations — fully aligned with documentation expectations from ISO 13485:2016 §4.1.3, EU MDR/IVDR Annex II (Section 4), Article 10.9, and FDA 21 CFR 820 (QMSR)
Why it matters
Whether you work in Medical Devices, IVD, Pharmaceuticals, or Biotech — expectations are increasing.
Regulators no longer accept fragmented awareness of requirements.
They expect a clearly defined regulatory scope — with documented reasoning, maintained over time.
Hoodin provides:
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Structured identification of applicable regulatory frameworks based on product and company context
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Continuous awareness of regulatory, standard, and guidance updates affecting your defined scope
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Documented, traceable rationale behind scope decisions
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Exportable records that support audit preparation and inspection readiness
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A system that complements existing QMS by adding a governed regulatory layer