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REGULATORY READINESS & CERTIFICATION
Compliance Alignment & Market Access
Navigating the evolving landscape of IoT product regulation - with assessment deliverables structured for regulatory submission, certification, and market access across the EU, UK, and US. We map findings directly to the frameworks your regulators require.
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EU Cyber Resilience Act & ETSI EN 303 645 - gap analysis and compliance evidence packaging
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UK PSTI Act readiness - assessment against mandatory consumer IoT security requirements
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FDA premarket cybersecurity guidance - medical device security documentation and submission support
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Board–ready compliance reporting - executive risk narratives with remediation timelines
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