Quality Assurance

SCANCO Medical utilizes a process-oriented management system that reflects the company’s three operative activities: management; resources; and implementation. This process fulfills the requirements of:

  • ISO 9001:2008
  • ISO 13485:2003
  • Full QA System for peripheral QCT [Annex II.3 of the Medical Device Directive (MDD) 93/42/EEC]
  • Medical Devices Ordinance MepV SR 812.213 (Switzerland)

For more information, download our Quality Management Handbook.


Quality Commitment


All SCANCO Medical employees are bound to the quality management system, which relies on their active contribution and cooperation. In a process of continuous self-improvement the defined corporate practices and processes are carefully monitored, corrected and refined.

Active employee participation in this improvement process is expected and constructive contributions encouraged.




Quality Assurance Certificates


ISO 9001 / 13485

 

EC: Full QA System

 

ISO 13485 (CMDCAS)