LOOPAL is pioneering deterministic, AI-native auditing infrastructure for the MedTech, Digital Health, and SaMD (Software as a Medical Device) industries.

We are solving the MDR/IVDR/AI ACT compliance bottleneck. Instead of forcing teams into heavy, expensive eQMS platforms, LOOPAL acts as a smart overlay. We integrate directly into the tools your engineering and QARA teams already use (like Atlassian Jira & Confluence) to provide real-time, continuous compliance without compromising data sovereignty. 

Why LOOPAL?
✅ Deterministic Architecture: We strictly separate regulatory rules (MDR, EU AI Act, ISO 13485) from the LLM, completely eliminating AI hallucinations.
✅ Continuous Compliance: We scan documentation and traceability matrices on the fly, catching regulatory gaps before the notified body audit.
✅ Seamless Integration: Built to live where you work. No more manual map-and-trace in outdated systems.
✅ Cost & Eco-Efficiency: Powered by smart hashing and token-optimized models, ensuring high-stakes compliance at a fraction of the traditional cost and energy footprint.

Loopal

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Loopal

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