Regulatory Intelligence Hub is the regulatory practice of AE Consulting. We help manufacturers, importers and distributors bring medical devices to the EU market and keep them compliant over time.
Regulatory compliance isn't an obstacle to endure — it's a pathway to govern. We combine vertical medical-device expertise with digital tools that speed up analysis and documentation. AI saves us time on repetitive work; the sign-off of a certified PRRC ensures every file holds up in an audit. In one line: AI for speed, human expertise for validity.
MDR, IVDR and go-to-market strategy: we guide startups from design to certification.
ISO 13485 and 9001: we prepare companies to pass the notified body audit.
AI tools for compliance and privacy-by-design, with legal support for complex GDPR matters.
Tell us where you are with your device: we'll tell you where you're exposed and how to reach the market faster.
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