About Artifakt Vigilance
Search vigilance
databases at once.
Artifakt Vigilance compresses hours of FDA MAUDE / BfArM / MHRA / literature crawling into one query, then turns the results into MDCG 2022-21 PSUR drafts that already follow the template a notified body expects. Free for the community, no signup required to search.
What it does
Search 8 vigilance databases
Adverse events, recalls and literature across FDA, BfArM, MHRA and PubMed in one query - the work that used to take an afternoon, in under a minute.
Draft MDCG 2022-21 PSURs
The exact section structure EU notified bodies expect, drafted from your search results. You review, edit, and own the final document.
Auto-archive your runs
Signed-in users get a private dashboard that keeps every search and every PSUR draft alongside who ran it and when - auditable history without manual bookkeeping.
Data sources
Eight databases, one query.
Selected per search via the source toggles on the landing page.
FDA MAUDE
The largest public database of medical-device adverse events. Millions of records, updated weekly.
FDA Recalls
Manufacturer-initiated and FDA-mandated recalls with class I / II / III labels.
BfArM (Germany)
Field-corrective-action notices from the German Federal Institute for Drugs and Medical Devices.
MHRA (United Kingdom)
Device alerts and safety notifications from the UK regulator.
Health Canada
Medical-device recalls, field safety corrective actions and safety alerts from the Recalls and Safety Alerts database.
PubMed
Biomedical literature from the US National Library of Medicine. Clinical studies, case reports, reviews.
Europe PMC
European-focused scientific literature - complements PubMed with additional open-access publications.
ClinicalTrials.gov
Registry of clinical studies for PMCF monitoring. Ongoing and completed device trials.
The Artifakt context
One product in a regulatory toolkit.
Artifakt Vigilance is built and maintained by Artifakt - a small, European team building the tooling EU medical-device manufacturers actually use day to day. Vigilance is the free part of that work: an SEO-friendly, no-signup-required tool that anybody in regulatory affairs can run a search on, and a soft funnel into the paid Artifakt portfolio for teams who want more.
The team's main project is the Artifakt Class I MDR Technical Documentation generator - a paid product currently in development for the November 2026 ADVZP conference in Prague. Vigilance ships first because the regulatory community needs a no-friction PMS search tool today. Founded by Oskar Slavicek, Czech OSVČ, ex-J&J regulatory.
Privacy
We hold the minimum we need to make this work.
What we store
- - Your Cognito sign-in record if you create an account (email, sign-in timestamps)
- - Your past searches and PSUR drafts, so the dashboard can show them back to you
- - A salted SHA-256 hash of anonymous visitors' IPs, only for the 3-per-day free-trial counter (the raw IP is never written to disk)
What we don't
- - Browsing outside the Artifakt Vigilance app
- - Third-party analytics / tracking pixels (no Google Analytics, no Meta Pixel, no Hotjar)
- - The raw text of regulator query responses past a short in-memory cache
Full detail in the Privacy policy and the GDPR Art. 15 / 17 controls in your Account page (data export + erasure).
Questions, feedback, partnerships?
We reply to every email - usually within a working day.