For medical device manufacturers and importers. EUDAMED data preparation, MDR documentation reviews and Polish–English Instructions for Use.
Contact by email. We respond within 3 business days.
Verified data for actor registration (SRN) and up to 5 devices, field mapping, registration support and a final report.
A report on gaps in technical documentation against MDR 2017/745, with priorities for corrections.
Polish–English Instructions for Use, including verification of MDR and EUDAMED terminology.
For non-EU manufacturers: an action plan and documentation within the agreed scope, covering AR and importer roles, EUDAMED and Polish registration matters.
We agree the scope, fee and timeline before work begins. Prices in EUR, excluding VAT. VAT treatment will be specified in the individual proposal. The MDR review is not a notified body audit; Gate to EU does not include acting as an Authorised Representative.
Not sure where to start? Tell us about your device and project stage — we will help define the scope of the initial discussion.
Quality engineer and founder of AZ Regulatory. Over 12 years of experience in the medical device industry.
Her work covers quality and technical documentation, MDR requirements and device registration. She personally reviews each document before it is handed over.
Email us about working togetherSupport for manufacturers, importers and medtech startups, and B2B subcontracting for QA/RA teams.
A finding should explain the problem, why it needs attention and what to do next.
The example shows how one inconsistency could be described in a report. The scope and priorities of an actual review depend on the device and the agreed work.
Explore the MDR review scopeIn this example, we clarify the discrepancy before reviewing the remaining documentation.
The initial consultation is 20 minutes, free of charge. We agree the work, fee, timeline and materials needed.
We prepare data or documents within the agreed scope. They undergo expert review before handover.
You receive the agreed deliverables and guidance on corrections and updates.
We sign an NDA before the project begins. We agree how to share documentation at the start of our work together. Do not send technical documentation or UDI data through WhatsApp.
AI tools support preparatory tasks and working drafts. Every document is reviewed and approved by Alicja Załanowska. Only public or anonymised material is used with cloud tools.
We provide advisory and documentation services. AZ Regulatory is not a notified body, law firm or certifying authority. Our services do not guarantee CE certification or a registration outcome.
A brief description is enough to begin. We respond within 3 business days with a proposed scope and fee.
Email us about your projectMonday–Friday, 9:00–17:00 Polish time.
We work in Polish and prepare documentation in English.
