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