Mode achieves ISO 13485 certification

Mode Sensors (MODE) is proud to announce its certification under ISO 13485, the internationally recognized standard for quality management systems in the medical device industry.

This certification underscores MODE’s commitment to delivering safe, reliable, and high-quality wearable healthcare solutions, including its flagship product, Re:Balans. 

“Achieving ISO 13485 certification is a major milestone for Mode Sensors, validating our dedication to meeting the highest standards in medical device development,” said Gøran van den Burgt, CEO of Mode Sensors. “This certification strengthens our ability to bring innovative hydration monitoring technology to market with the utmost focus on safety and effectiveness.”