Wide range of surface treatment

certification according to ISO 13485

Ready for medical technology

05.09.2018

Medical products must meet high standards in terms of reliability and safety. This includes also surface treatments of medical equipment – no matter of how small the refined part is.

BWB-Ampho SA ensures these quality requirements by a continuous circle of prove and improve: The certification pays extra attention to management responsibility, process screening and active risk management.
  

 

«Implementing the medical requirements in the existing ISO landscape was a challenge. All parties are very satisfied to have succeeded at their first attempt» states Urs Scheuber, head of quality management BWB group.

Serge Wainsenker, director of BWB-Ampho SA adds: «Now, we are ready to meet medical technology markets».

Over the past months BWB-Ampho employees have been working intensively to adopt internal processes and in order to establish the required quality management system.

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

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