A VNA is a Medical Device – Understanding the Requirements that Make Up a VNA

A VNA is a Medical Device.

A VNA is a device that meets the U.S. Federal requirements of a Class 1 medical device. This means that the VNA manufacturer registers its product and device manufacturing location with the FDA. The FDA makes sure that the device and its software is developed according to a quality system like those defined by U.S. Regulation 21 CFR 820, and has a complaint handling procedure in place. This requirement differentiates medical grade devices from off-the-shelf consumer devices.

  • A VNA is a Class 1 medical device
  • The manufacturer must register its product with the FDA
  • The FDA validates the quality of the device
  • This requirement differentiates a VNA from off-the-shelf products

For more information about developing a Vendor Neutral Architecture, the VNA Institute of Technology, or to enroll for CPHIMS (CE) Continuing Education Hours, visit http://www.vnait.org. For information about TeraMedica, visit: http://www.teramedica.com

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