Loopal
Deterministic AI auditing for MedTech regulatory compliance.
The founders
The company
Loopal is building a compliance intelligence platform that automates regulatory gap analysis and technical documentation audits for European medical device manufacturers. Its neurosymbolic architecture pairs deep document parsing with deterministic rule layers to verify Annex II dossiers, GSPR requirements and traceability matrices in days rather than months.
EU MDR and IVDR preparation currently swallows 6–12 months of manual work and upwards of €50,000 per technical file in external QA/RA retainers. Generative AI can't touch legally binding audits because of hallucinations — leaving a gap Loopal is designed to fill with 100% auditable, zero-hallucination checks.
The company was founded in 2026 in Cluj-Napoca by Andrei Lupu, targeting the grind of MedTech regulatory prep. Loopal's bet is that compliance auditing needs determinism, not probabilistic generation.
Loopal is early and pre-funding, so the proof will be in the product — but the founding team is building on a proprietary neurosymbolic approach and enterprise-grade, ISO-aligned security on AWS. That's a deliberate architectural choice aimed squarely at the trust problem in regulated audits.
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