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 9001:2015
- ISO 13485:2016
- Medical device single audit program (MDSAP) certification (for Japan and Canada)
- EU Quality Management System certificate for XtremeCT II, Regulation (EU) 2017/745 (MDR)
- Medical Devices Ordinance MepV SR 812.213 (Switzerland)
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.
