Quality - QMS
Setting up a simple and robust QMS

One of our missions is to support the compliance of your Quality Management System to applicable requirements by establishing a QMS that is both effective and efficient.

We provide support to design your Quality Management System (QMS) in alignment with the risk and the complexity of your device.

You can rely on us for:

  • Integration of multiple requirements (Directives, MDR, IVDR, ISO 13485, USA QSR, Japan Ord. 169, Brazil RDC 16/2013)
  • Setup of a compact and clear documentation structured around your actual processes
  • Training and support throughout the certification / approval process
  • Debugging, reshuffling and cleaning up of existing QMS
  • Readiness for MDSAP – Medical Device Single Audit Program

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

Updating and upgrading an existing QMS