ISO13485:2016 certification – Quality standard at Nivalit

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We are happy to announce that in December 2023, Nivalit successfully passed the surveillance audit of the quality management system for medical devices PN-EN ISO13485:2016. The PN-EN ISO13485:2016 certification not only affirms our existing standards but also underscores our commitment to prioritizing the highest quality.

Commitment to quality at all stages – ISO13485:2016 Certification

Taking on the burden of introducing and maintaining the certification, we are proud that the document confirms our commitment to an effective quality management system, covering all stages from design to production, installation, and operation of medical devices. It is not just a certificate, but proof of our readiness to meet industry requirements, and compliance with regulations and standards in the medical sector.

The process of maintaining PN-EN ISO13485:2016 certification required us not only to meet high standards, but also to demonstrate our readiness to meet industry requirements and regulations. This is an opportunity for us to reaffirm that our innovative medical solutions, such as the Mentalio project, are effective and safe.

Team collaboration is an essential element of success

We want to thank our entire team for their commitment and loyalty, enabling us to maintain our high-quality standards. The collaborative efforts of every member of our company contribute to our success and maintain the highest standards in our field.
We are proud of our innovative medical solutions, such as the Mentalio project, a dedicated support for mental health diagnosis for children and adolescents. The re-certification of PN-EN ISO13485:2016 is an affirmation of our willingness to continuously improve in the field of medical devices.