MDR/IVDR
Annex II (Section 4)
Article 10.9
ISO 13485
§4.1.3
ISO 13485
§820.30
UPDATES
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.
Regulations keep changing. Can your evidence keep up?
To stay compliant, you need more than identification of applicable regulations. RA/QA teams must:
Justify inclusions and exclusions
Document and defend every regulatory requirement decision
Validate conformity methods
Ensure your compliance approach meets regulatory standards
Maintain structured, auditable evidence
Keep comprehensive documentation ready for inspection
The Solution
Hoodin gives you a system that evolves with every update — delivering traceable, audit-supporting documentation for confident compliance, in line with Annex II (Section 4), Article 10.9 MDR/IVDR, and FDA 21 CFR 820.
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HARMONISATION
Prove alignment. Spot deviations.
National rules often diverge from EU MDR, IVDR, FDA frameworks and cross-domain regulations. Hoodin maps every parent regulation to its local variants — clearly showing where markets align, and where deviations create additional requirements.
GAIN REAL-TIME CONTROL
Meet the Smart Compliance List
The only system built to identify, justify and maintain your applicable regulations — per product, per market, in real time. Always traceable, always audit-supporting.
Compliance That Works for You
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Always know what applies — tailored to your product and markets
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Audit-supporting traceability — every source, every version, fully documented
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Structured outputs for action — feed compliance steps directly into your technical file
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Credibility assured — validated and official sources only
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Reduce effort, lower risk — eliminate manual tracking and gaps before audits
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SMART COMPLIANCE LIST
One List. Every Regulation. Audit Supporting.
The AI-supported tool for RA/QA teams to identify, justify and monitor applicable regulations across Europe and North America — delivering the documented evidence required by Annex II (Section 4), Article 10.9, ISO 13485 §4.1.3 and FDA 21 CFR 820.
TRANSITIONS
Stay ahead of regulatory change
Transition deadlines and proposals are tracked directly in your list, flagging outdated rules and highlighting upcoming changes — so you can prepare in advance, not scramble under audit pressure.
SMART COMPLIANCE
