Mindpeak GmbH, leading innovator in AI software for pathology, proudly announces its Quality Management System (QMS) has successfully received ISO 13485:2016 certification from the British Standards Institution (BSI).
This certification validates Mindpeak’s commitment to designing and delivering high-quality products that meet rigorous international standards for safety, reliability and regulatory compliance.

ISO 13485:2016 is the global benchmark for quality management systems in the medical device industry, ensuring that manufacturers meet rigorous regulatory requirements.

Commenting on the achievement, Felix Faber, CEO and Co-Founder of Mindpeak, said:

“Achieving ISO 13485:2016 certification from BSI highlights our dedication to providing safe, reliable, and high-performance medical solutions. It also reinforces our position as a trusted partner in the healthcare industry, ensuring that every product we manufacture meets the highest standards of safety and reliability.”

Operating in one of the most regulated sectors, Mindpeak places patient safety and product quality at the forefront of its operations. This certification from BSI is a testament to the company’s rigorous approach to regulatory compliance and its dedication to ensuring that all products meet or exceed global standards for safety and performance.

About Mindpeak

Founded in 2018, Mindpeak is a global innovator in AI-driven digital pathology solutions. The
company develops cutting-edge algorithms that support pathologists in routine diagnostics,
focusing on automating tissue analysis for faster, more accurate results. Mindpeak’s platform
is designed to enhance productivity and diagnostic confidence in clinical labs, helping to
improve patient outcomes in cancer care.