RQS – Roman Quality Support is a consulting and training company operating continuously since 2004. Our main scope of activity is advisory services related to medical devices.
We were the first entity in Poland to obtain EU REP status: PL-AR-000002484
Our services include:
- Acting as Authorised Representative in the European Union[ EU REP ] pursuant to Art. 11 MDR
- Acting as Person Responsible for Regulatory Compliance[ PRRC ] pursuant to Art. 15 MDR
- Implementation of Quality Management Systems compliant with EN ISO 13485
- Preparation for certification audits or EN ISO 13485 / MDR / IVDR surveillance
- Development and verification of technical documentation for medical devices compliant with Art. II + III MDR
- Risk analysis in accordance with EN ISO 14971
- EUDAMED database management
- UDI codes + GS-1 database management
- Registration / notification of competent authorities for medical devices
- Identification of legal requirements for medical devices placed on the market
- Training of employees, auditors and Quality Representatives in medical devices
- Support with export, import and distribution of MDR / IVDR compliant products
Have questions? Call or write – we always respond.
RQS is founded on providing clients with long-term care and expert support even after project completion – as a Partner, not just a contractor.