17Quality

 18Control

System

Our Quality System is certified under ISO 13485:2016 Medical Device and ISO 9001:2015.

 

 


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ISO 9001:2015             ISO 13485:2016

 

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Quality policy

Process

Process and product monitoring and control throughout production based on Risk Management criteria.

We have highly accurate measuring equipment for product control, including a contactless 3-D optical and digital size control system.


20

Clean Rooms

We have equipment and spaces complying with Clean Room Class 7 conditions, per ISO 14644-1.

Environmental control of the bacterial load for both component injection and product packaging.


19

Clean Rooms