MD QMS SRL is accepted as an economic operator in EUDAMED — a precondition for acting as your importer, and for the Authorised Representative role we are bringing online next.
Registered in EUDAMED
The threshold between your device and the EU market.
For manufacturers outside the EU, the Single Market has a doorway — and someone has to stand in it. MD QMS SRL is your EU-based importer, registered in EUDAMED and built inside an established medical-device quality and compliance practice. Our EU Authorised Representative service is in development and will launch soon.
Why a manufacturer hands us this responsibility
This isn’t a registered address that forwards post. MD QMS SRL is run by a named medical-device quality and regulatory practitioner — ISO 13485, ISO/IEC 27001 and MDR work, hands on.
MD QMS SRL sits alongside an established UK compliance and technology consultancy. The importer role — and the representative role once it launches — is backed by the same people who do the underlying QMS and regulatory work.
Importer today, Authorised Representative next
A non-EU manufacturer typically needs both an EU Authorised Representative and an EU importer to place a device on the market. We hold the importer role now and are bringing the representative role online next — kept distinct, because the two answer to different obligations.
EU Authorised Representative
Your future legal point of presence in the Union — named on your documentation and acting as the manufacturer’s contact for EU competent authorities, under a written mandate. In development; not yet live.
Read more about this role →Importer
The EU-established operator that places your device on the market. Before a product crosses the threshold, an importer has to verify that the conformity, marking and registration are in order. That verification is the job.
How the importer role works →Leadership
The people behind the mandate
MD QMS SRL is run by named practitioners, not a registered address. Here is who you would actually work with.
Alex Adamovici
Senior Consultant, MD QMS SRL
Alex is a senior consultant covering MD QMS SRL’s technical and governance side, with a security-first background spanning cloud architecture, identity and access management, and infrastructure engineering across regulated industries. He is an ISO/IEC 27001:2022 Lead Auditor and holds a certification in ISO 14971 medical device risk management.
His career has been built across cloud infrastructure, identity engineering, and release and risk governance in regulated environments — the systems discipline he brings to how MD QMS SRL documents and governs its importer role, and the Authorised Representative role now in development.
View LinkedIn profile →
Mirela Adamovici
Senior Compliance Consultant, MD QMS SRL
Mirela is a regulatory compliance specialist with hands-on knowledge of GMP, ISO 13485, ISO 14971, ISO 9001, MDR, EUDAMED and FDA 21 CFR Part 820. She has implemented and maintained quality management systems from the ground up, led ISO certification programmes, and works as a qualified internal auditor.
She also brings a strong procurement and logistics background — supplier qualification, import/export operations, customs compliance and international shipping — the operational grounding behind the verification work MD QMS SRL’s importer role requires.
View LinkedIn profile →
Andreea Moruz
Managing Director, MD QMS SRL
Andreea leads MD QMS SRL’s day-to-day operations, coordination and client relationships. She is a qualified medical assistant, currently practising in family medicine, and has trained as an instructor for the European Resuscitation Council — a clinical, patient-facing perspective on how device documentation and compliance paperwork hold up in real use.
Her earlier experience spans public procurement, supplier and customer coordination, and operational reporting, which she applies to keeping MD QMS SRL’s import records and client communications organised and audit-ready.
View LinkedIn profile → On the roadmap
Authorised Representative — launching next
Our EU Authorised Representative service is in development and not yet open for mandates. Beyond that, MD QMS SRL will also offer compliance and consultancy packages for the European and Romanian market. We’re building both deliberately rather than listing services we can’t yet stand behind. Want to be told when AR launches? Say so on the call.
The MD QMS family
MD QMS SRL is the EU market-access arm of a wider quality, regulatory and technology practice. If you need the underlying QMS, regulatory strategy or cybersecurity work, that capability already exists across the group.
Need an EU importer you can actually reach?
Tell us what you make and where you’re selling. We’ll tell you plainly whether we can help and what it costs — and let you know the moment our Authorised Representative service opens.