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.

Hsinchu, Taiwan, October 25, 2017 – The leading custom ASIC company, Global Unichip Corp. (GUC), today announced the achievement of highly coveted ISO 13485:2016 certification, which make GUC the ...

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 ...