RQS

RQS – Roman Quality Support is a consulting and training company that has been operating continuously since 2004. Its main area of activity is providing advisory services related to medical devices.
We were the first entity in Poland to obtain EC REP status: PL-AR-000002484

In our offer, you will find services related to:

• Performing the duties of an Authorized Representative in the European Union
[ EC REP ] in accordance with Article 11 of the MDR
• Performing the duties of a Person Responsible for Regulatory Compliance [ PRRC ] in accordance with Article 15 of the MDR
• Implementation of a Quality Management System compliant with the EN ISO 13485 standard
• Preparation for certification or surveillance audits in accordance with EN ISO 13485, MDR, or IVDR
• Development and/or verification of technical documentation for medical devices in accordance with Articles II and III of the MDR
• Development of risk analysis in accordance with EN ISO 14971
• Support with managing the EUDAMED database
• Support with UDI code management and the GS-1 database
• Registration and/or notification of competent authorities regarding medical devices
• Identification of legal requirements related to placing medical devices on the market
• Training of employees, auditors, and Quality Representatives in the field of medical devices
• Assistance with the export, import, and distribution of medical devices compliant with MDR / IVDR

Have questions? Call or write to us - we always respond.

The guiding principle of RQS is to provide clients with long-term care and professional support - even after the completion of a project - as a true Partner, not merely a Service Provider.