• by: Admin
  • January 1st, 2017
  • Category: quality

October 2023: OptimaT achieves ISO13485:2016 certification for the 2nd time in a row!


We are very proud to announce that we have successfully passed the international ISO13485:2016 standard audit. And this for the 2nd time in a row!

Successfully passed the international ISO13485:2016 standard audit for the second time!

We proudly announce that we have successfully passed the international ISO13485:2016 standard audit. And this for the 2nd time in a row!

With this quality label, we can confirm that the medical devices we assemble and package in OptimaT meet the strict legal quality and product requirements. Think of special regulations for clothing, cleaning, closely monitored working methods, ... comparable to an operating theatre. In addition, there is a constant supply of freshly filtered air and evacuation of consumed air in our clean room to ensure all this.

In this way, we can guarantee a professional and high-quality approach for our customers!

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