gMendel® has successfully passed the ISO 13485 audit for the third consecutive time!

February 26, 2024, Copenhagen – We’re delighted to announce that gMendel® has successfully passed the ISO 13485 audit for the third consecutive time — a stellar reflection of our consistent dedication to quality. 

Not a single “non-conformity” was identified during the assessment, and no issues were carried over from previous visits.

This rigorous evaluation reaffirms that our Quality Management System (QMS) is well-suited to our company’s scale and the scope of our activities. It underscores our capacity to consistently provide high-quality In Vitro Diagnostic Medical device software that meets both regulatory and standard requirements. We’re thrilled to continue using the ISO 13485:2016 certification as a mark of excellence in our design, development, and service provision. 

This achievement wouldn’t have been possible without the dedication and hard work of our exceptional team. We extend our heartfelt gratitude to our esteemed partners, Antonina Burlachenko and Lukasz Kilianek, for their trust and support. Together, we’re poised to uphold our commitment to excellence and drive innovation in the medical device software industry.