Loopal
Deterministic AI auditing for MedTech regulatory compliance.
The founders
The company
Cluj-based Loopal is building a compliance intelligence platform that automates regulatory gap analysis and technical documentation audits for European medical device makers. Its neurosymbolic architecture pairs deep document parsing with deterministic regulatory rule layers to verify Annex II dossiers, GSPR requirements and traceability matrices — the company says with zero hallucinations and full auditability.
Preparing a single technical file for EU MDR and IVDR can take 6–12 months and cost upwards of €50,000 in external QA/RA retainers, while generic generative AI is unusable for legally binding audits because it hallucinates. Loopal's deterministic approach targets that gap directly.
Founded in 2026 by Andrei Lupu, the company is tackling a problem where accuracy is non-negotiable — betting that rigid rule layers, not probabilistic models, are what regulated MedTech actually needs.
The founding team has chosen a deliberately narrow, high-stakes wedge — deterministic, auditable verification for medical device compliance — rather than another general-purpose AI wrapper, which suggests real conviction about the regulatory problem.
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