Quality

At PCU, quality is of paramount importance and it is therefore self-evident that we work to the latest standards.


In order to guarantee you a constant quality, we work according to the international standard for quality management systems for medical devices: NEN-EN-ISO-13485.


All our products meet the highest requirements according MDR 2017/745



Certifications:

  • ISO 13485 certificate
  • CE MDR 2017/745 certificate


To continuously improve our processes, product quality, and environmental performance, we are implementing an environmental management system that meets the requirements of ISO 14001.

PCU has developed a policy statement regarding ISO 14001.
If you are interested in this policy statement, you can request it via info@pcu-bv.nl.