ISO 13485 certified and multiple medical clean rooms
From low to high volume production needs, the benefits of partnering with Genesis Plastics Welding for medical device clean room manufacturing are numerous.
Genesis Plastics Welding Manufacturing Facilities
- Two certified Class 7 Medical Clean Rooms are available around the clock depending on production demand.
- Genesis is an ISO 13485 certified contract manufacturer providing RF welding and heat sealing applications of plastic products.
- Meet FDA requirements for contract manufacturing of Class I, Class II and Class III medical devices and components.
- Our quality system is compliant with Medical Device Quality System Regulation 21 CFR 820 for Class I, Class II and Class III medical device and component manufacturing.
- Continuously evaluated quality systems ensure tight control to production specifications and timelines, delivering customer satisfaction.
- Plastics sealing technologies include: impulse, ultrasonic and RF welding. Assembly and packaging also can be completed in the medical clean rooms.
- Assembly and packaging of medical devices – in or out of the Clean Room environment.
Learn more about our medical device contract manufacturing and fluid bag capabilities.