A New Era of Open Source Medical Device Development ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices.

“Our mission has always been to break down barriers—whether in diabetes technology, regulatory transparency, or industry collaboration,” said Jake Nardone, Tidepool’s Head of Quality and Regulatory ...

Tidepool, a nonprofit organization dedicated to empowering the diabetes community through open-source innovation, proudly announces it has achieved ISO 13485:2016 certification from accredited ...

proudly announces it has achieved ISO 13485:2016 certification from accredited certification body TÜV SÜD America for its open-source Quality Management System (QMS), known as qmsOS. This ...

whether in diabetes technology, regulatory transparency, or industry collaboration," said Jake Nardone, Tidepool's Head of Quality and Regulatory Affairs. "Achieving ISO 13485 certification for an ...

This internationally recognized standard demonstrates Nabsys' dedication to maintaining a robust and effective quality management system. The ISO 9001:2015 certification underscores Nabsys ...

The integration of ISO 9001:2015 with these standards provides a comprehensive framework for a centralised quality management system, aiding in regulatory approvals for exports and high-quality ...