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Knowledge base

EUDAMED and MDR in QA/RA practice

Checklists and sequencing from Alicja Załanowska’s practice — for QA/RA in SME medtech, not for a law firm brief.

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 and EUDAMED: when to register vs distributor

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.