“Medical Device Registrant Scheme” is a groundbreaking pilot program in Guangdong Province that allows qualified device companies to commission licensed third party for product manufacturing. Among the earliest adopters, SiBionics has established rigorous manufacturing and quality management systems that meet the program’s stringent requirements for Class III medical device manufacturing commission. Therefore we are able to experiment with a new model of open production platform across entire SiBionics group to achieve utmost efficiency and cost-effectiveness.
SiBionics has built GMP-compliant Class 1000 clean room facility on site, totaling 1500 square meters. It is equipped with cutting edge active implantable medical device production equipment such as atmosphere protection laser welding system, ultrasonic welding system, and micro injection molding system etc. Other advanced testing equipment such as helium mass spectrometer leak detector, miniature push-pull force testing machine, and measuring microscopes provide quality assurance for the production of active implantable medical devices. We continue to invest in hardware platform upgrade and strive to create an open production platform for active implantable medical devices.
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