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]
  • 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

ISO9001:2008

 

ISO 13485:2003

EC: Full QA System for pQCT

 

ISO 13485:2003 (CMDCAS)

 
 
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