Medical Device Cleanroom Manufacturing

Medical Device Cleanroom Manufacturing

Multiple medical cleanrooms with ISO 13485 certification
From low to high volume production needs, the benefits of partnering with Vonco for medical device cleanroom manufacturing are numerous.

Vonco Manufacturing Facilities

  • Three certified Class 7 Medical Cleanrooms are available around the clock depending on production demand.
  • Vonco is an ISO 13485:2016 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 cleanrooms.
  • Assembly and packaging of medical devices – in or out of the cleanroom environment.

Learn more about our medical device contract manufacturing and fluid bag capabilities.

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