SETTING UP A SIMPLE, FLEXIBLE AND ROBUST QMS

Medidee possesses the talent and expertise to create a compliant Quality Management System (QMS), according to the ISO 13485 and other applicable regulatory requirements.

Our primary mission is to establish a Quality Management System which is suitable, adequate, and effective.

We provide support to design your Quality Management System in alignment with the risk and the complexity of your device, tailoring it to the needs of your organisation, and taking into account specific performance and customer requirements.

You can rely on us for:

  • Successful ISO 13485 certification
  • Integration of multiple requirements (Directives, MDR, IVDR, ISO 13485, USA QSR, Japan Ord. 169, Brazil RDC 16/2013) into the scope of the QMS
  • Compilation of compact and clear documentation reflecting the structure and the processes of your organisation
  • Flexible QMS documentation, easily adaptable to changes and improvements
  • Training and support throughout the certification / approval process
  • Auditing and restructuring of existing Quality Management Systems
  • Readiness for MDSAP – Medical Device Single Audit Program

Medidee is following state of the art IMDRF & MDSAP Guidances.
Our subsystem-based approach ensures straightforward integration of GMP requirements, easy and safe implementation in daily routine, and efficiency of the QMS as a tool supporting corporate management.