Cardiolife Secures ISO 13485:2016 Certification

Digital Logic Kardio Software SA, the company developing the AI-powered ECG analysis software, Cardiolife, has successfully obtained ISO 13485:2016 certification for its Quality Management System (QMS), establishing its commitment to the highest standards of quality, safety, and regulatory compliance in medical software development.

ISO 13485:2016 is the internationally recognized standard for quality management systems in the medical device industry, ensuring that companies meet strict regulatory and customer requirements for the design, development, and production of medical devices.

"Achieving this certification is a testament to our dedication to developing safe, reliable, and high-quality AI-driven solutions for cardiovascular diagnostics," says CEO, Kristin Lied.

The certification follows an extensive and thorough audit conducted by DNV, a prestigious European Union Notified Body, confirming adherence to global best practices in medical software development.