About

A regulatory importer you can hold accountable

MD QMS SRL gives non-EU medical device manufacturers an EU-based regulatory importer that knows the work and answers when you call. The same people do the underlying regulatory work.

Where we come from

MD QMS SRL is the Romania-based, EU market-access arm of the MD QMS group, an established quality, regulatory and technology practice. The group’s work spans ISO 13485 quality systems, EU and UK MDR, FDA submissions, ISO/IEC 27001 information security and medical-device cybersecurity. The regulatory importer role offered here draws on that experience.

Standards we work to

ISO 13485: medical device quality management systems
EU MDR (Regulation (EU) 2017/745) and UK MDR
ISO/IEC 27001: information security management
IEC 62304 / ISO 14971: software lifecycle and risk management

Leadership

The people behind the regulatory importer role

These are the people you would actually work with.

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, 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 uses to keep MD QMS SRL’s regulatory importer records and client communications organised and ready for audit.

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 the regulatory importer role requires.

View LinkedIn profile →

Alex Adamovici

Senior Consultant, MD QMS SRL

Alex covers 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 behind how MD QMS SRL documents and governs its regulatory importer role.

View LinkedIn profile →

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, our UK sister company MD QMS Ltd. provides it, with the roles kept separate.

Visit MD QMS Ltd. →

Need an EU regulatory 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.

Book a free 30-minute call

Or send us an outline. We reply within two working days.