About
A representative you can hold accountable
MD QMS SRL exists for one reason: to give non-EU medical device manufacturers an EU-based importer — and soon, an Authorised Representative — that is genuinely competent and genuinely reachable, backed by people who do the underlying regulatory work, not a brass plate.
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 importer role offered here — and the Authorised Representative role we’re bringing online next — are backed by that capability.
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
Current status
MD QMS SRL is registered in Romania and accepted as an economic operator in EUDAMED. The importer role is live. Our EU Authorised Representative service is in development and not yet open for mandates. Compliance and consultancy packages for the European and Romanian market are also in development.