AZ RegDocs
EUDAMED Express
Actor registration (SRN) + up to 5 devices in EUDAMED. Data checklist, field mapping, expert verification, final report.
Boutique regulatory studio for medical device manufacturers and importers. Fixed-price, fast delivery — with expert accountability, not AI-only output.
Mandatory EUDAMED registration — economic operators and devices (Actor + UDI modules)
Clear scope, fixed fee, defined timeline. No retainers you don't need.
Actor registration (SRN) + up to 5 devices in EUDAMED. Data checklist, field mapping, expert verification, final report.
Technical documentation review vs MDR 2017/745. Gap report with remediation priorities — not NB certification.
Instructions for Use translation PL↔EN with regulatory terminology verification — not generic translation.
EU market entry for non-EU manufacturers (USA, UK, Turkey): AR, importer, EUDAMED, initial documentation.
Person Responsible for Regulatory Compliance (MDR Art. 15) — monthly retainer. Micro and small manufacturers only.
AZ Regulatory was founded by Alicja Załanowska — a quality engineer with 12+ years in medical devices (ISO 13485, national registration, technical documentation).
We combine expert regulatory knowledge with AI tools to deliver faster — but every deliverable is reviewed and signed by a human. We are not a notified body or law firm.
SME medical device manufacturers, importers, non-EU companies entering the European market, and medtech startups.
Transparent workflow — you know what you get and when.
Free initial call. We define scope, timeline, and client data checklist.
Data mapping, working document versions, consistency check vs MDR/EUDAMED.
Alicja Załanowska verifies every deliverable before handover.
Final report, registration confirmation, update instructions. Post-project support.
Fixed fee and clear scope. EUDAMED Express in 3–5 business days — not weeks of waiting.
12+ years in medical devices. Every document verified by a specialist with ISO 13485 experience.
Client data stored locally, anonymised before AI. NDA before project start.
Describe your situation briefly — we respond within 1 business day with scope and pricing.
Fastest response via email and WhatsApp during business hours (Mon–Fri, 9:00–17:00 CET).
Send email WhatsAppDo not send technical documentation or UDI via WhatsApp — use email.