Qalico

Monitor every source. Surface only what matters.

Qalico watches every authority, standards body, and notified body your devices depend on — then classifies and routes each update to the right product, reviewer, and process.

Qalico regulatory update feed with filter and triage UI

Authoritative coverage, globally: Over 200 regulatory bodies, standards organizations, and notified bodies monitored continuously — FDA, EMA, MHRA, Health Canada, PMDA, NMPA, ISO, IEC, IMDRF, and dozens more.

FDA
European Commission
ISO
PubMed
ANSM
IMDRF
EFSA
HSA
NHA
EMA

how it works

The bottleneck in regulatory monitoring isn't access to documents; it's filtering signal from noise. Qalico crawls 200+ authoritative sources on a fixed cadence, captures every new publication with a full audit trail, scores each update against your registered portfolio, and routes the relevant ones to the people who own the response. Reviewers stop scanning weekly digests and start receiving targeted, actionable items.

Qalico update card showing FDA guidance change detected within hours

Real-time change detection

Every page is fingerprinted. When a document, guidance, or standard is updated, Qalico detects the diff within hours, not weeks.

Qalico document history view with timestamped regulatory source capture

Full audit trail

Each captured update is stored with its original URL, retrieval timestamp, and source hash — so you can prove what was published and when, even after agencies revise or delete it.

Portfolio filter showing Classification Class II and Product code LLZ

Portfolio-aware relevance scoring

Updates are scored against your registered device portfolio, product codes, intended uses, classifications, and target markets, so reviewers only see what applies.

Multi-axis tag cloud showing jurisdiction, priority, document type, and standard classifications

Multi-axis classification

Each update is tagged across jurisdiction, document type, topic (cybersecurity, biocompatibility, software, etc.), affected device classes, and effective dates.

MDCG 2019-11 update card flagged as High priority with effective date

Priority

High-impact updates (new obligations, imminent effective dates, recalls) are flagged automatically so they jump the queue.

Slovenian regulatory document with language selector showing English, German, Japanese, French

Multilingual capture

Native-language documents from non-English jurisdictions are captured and translated, so coverage isn't limited to what publishes in English.

@preview

Book a 30-minute walkthrough tailored to your device portfolio and regulatory scope.