PAICON Certified by TÜV

We are proud to announce that PAICON GmbH has been officially certified by TÜV SÜD in accordance with ISO 13485:2016, a globally recognized standard for quality management systems for medical devices.

The certificate confirms that PAICON has implemented and maintains a robust quality management system for the design and development of in-vitro diagnostic AI-supported software applications for imaging data analysis in oncology.

This certification marks a major milestone in our mission to bring trustworthy, high-quality, and regulatory-compliant digital health solutions to the field of oncology. It reflects our commitment to meeting the highest international standards and our ongoing dedication to patient safety, innovation, and regulatory excellence.

Building Trust in AI-Powered Digital Health

As we continue to grow and expand our impact in personalized medicine and AI-driven diagnostics, this certification empowers us to build further trust with our partners and clients across the healthcare ecosystem.

It also highlights our readiness to meet the stringent requirements of the medical device industry and reinforces our focus on delivering compliant, reliable, and impactful solutions at every stage of the innovation process.

Thank you to our dedicated team and partners for their contributions in achieving this important step forward. We look forward to delivering even greater value through compliant, innovative, and life-changing digital health technologies.

Verify our TÜV Certificate

🔗 Verify the Certificate on TÜV SÜD’s website