Portfolio-aware monitoring
Register your devices once — classifications, intended uses, target markets. Qalico filters the global regulatory stream down to what actually affects your products.
The regulatory operating system for medtech
From single-product startups to global multinationals, Qalico gives QA/RA teams one place to monitor every market, triage every regulatory change, and assess impact with full traceability.
how it works
Medtech regulatory work is fragmented across jurisdictions, document types, and internal teams. Qalico consolidates it: every authority your devices touch, every standard you cite, every notified-body publication you depend on — monitored continuously, classified against your portfolio, and routed to the people who own the response. Built for ISO 13485 and 21 CFR Part 11 environments from day one.
Audit-ready by default
Every captured update, redline, and impact assessment is timestamped and sourced. Export audit packs straight from the platform for ISO 13485, EU-MDR, and FDA QSR reviews.
Built for QMS integration
Connect Qalico to your QMS, RIM, or eQMS via API and webhooks. Updates trigger change-control records automatically; reviewer decisions flow back into your system of record.
Software validation support (GAMP 5-aligned)
IQ environment checklist, OQ traceability matrix against relevant ISO standards re-tested after every update, and PQ guided dataset validation with formal test reports for your QMS.
From startup to enterprise
Start with a single product and a one-person QA team. Scale to hundreds of devices and dozens of reviewers across regions without changing platforms.
Multilingual, global coverage
Native-language capture from PMDA, NMPA, ANVISA, KFDA, and 140+ other authorities — translated and normalized so coverage isn't limited to English-speaking markets.
See Qalico for your medtech portfolio
Book a 30-minute call. We'll walk through coverage for your device classes and target markets, and show how Qalico fits into your existing QMS.