Manufacturing and Quality Control

The Manufacturing and Quality Control team at Rose Medical is responsible for the precise assembly and production of custom medical devices, leveraging CNC machining and injection molding capabilities within class 7 (10,000) clean rooms. This team ensures that all devices meet stringent ISO 13485:2003 standards through rigorous quality checks and testing procedures. Their detailed approach encompasses everything from short-term pilot runs to long-term production, ensuring that both sterile and non-sterile devices are packaged and ready for sterilization, meeting FDA regulations for medical device manufacturing.