Quality Standards

Prostatype Genomics AB is committed to ensure customer satisfaction while meeting applicable legal, statutory and regulatory requirements. This is accomplished through our quality system that enables us to effective and continuous improvement when it comes to meeting the needs of our customers and the community.

The hallmark of Prostatype Genomics is to develop and produce products of highest quality. The process of production through designing, manufacturing, distribution, and usage, follow the quality standards for medical devices.


Prostatype® Test System Quality Standards

  • The Prostatype® Test System is CE-marked since January 2016.
  • Prostatype Genomics AB is certified according to ISO13485:2016 since July 2016.
    ISO Certificate
  • All manufacturing is done according to GMP.