Bambi Medical ISO 13485 Certified
We are happy to share that our client Bambi Medical received the ISO 13485:2016 certificate. Bambi Medical is now officially certified for the design and development processes of their neonatal monitoring systems. ProductStream congratulates the team of Bambi with this achievement!
The Bambi-Belt consists of a disposable strap with a sensor module and a portable monitor. The sensor module sends the signals from the band via Bluetooth to the portable monitor, which shows the heart rate, breathing and skin temperature of the premature children. Via a link with the Philips IntelliVue system, the data from the Bambi Belt can be displayed on the Philips monitor in the neonatology department.
Making Baby’s lives Happier
Instead of many sensors that are glued to each sensor and where removal is painful, the sensors are now in one band. Parents can now also take their baby out of the incubator independently. More can therefore be cuddled!
Arena Training Management
Nice training session during the implementation of Arena PLM / QMS at Bambi Medical located at the High Tech Campus in Eindhoven. Familiarity with SOPs is investigated in Arena PLM / QMS using quizzes.