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.