EUDAMED and MDR in QA/RA practice
Checklists and sequencing from Alicja Załanowska’s practice — for QA/RA in SME medtech.
EUDAMED mandatory — what to change in the company (RA checklist)
Actor vs UDI, who is LAA, week-by-week QA/RA actions.
How to get an SRN in Poland: EUDAMED + URPL in practice
Step order, common application gaps, Submitted → Registered.
Importer or distributor: EUDAMED registration
Economic operator roles with PL examples — common mistakes.
MDR gap analysis: how to read a gap report before NB
Remediation priorities vs a certification audit.
Informational material only — not legal advice. AZ Regulatory is not a notified body.