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
  • Full QA System for peripheral QCT [Annex II.3 of the Medical Device Directive (MDD) 93/42/EEC]
  • Japanese Pharmaceutical Affairs Law (PAL)
  • 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.

Quality Assurance Certificates



ISO 13485:2016

EC: Full QA System for pQCT


SCANCO Medical AG | Fabrikweg 2 | CH-8306 Brüttisellen | Phone +41 (0)44 805 98 00 | Fax +41 (0)44 805 98 01 | info@scanco.ch | www.scanco.ch