FDA Class I/II Devices

Zymetrix has extensive experience in testing Class I and Class II medical devices.  In most of these cases, testing was not required to meet regulatory requirements, but rather to support effective product design.  Zymetrix can advise on operational mechanical loads, as well as the development of appropriate test setups and protocols.

Examples of some of the testing we've performed to help get devices to market include:

  • fatigue testing of a shoe insole with embedded pressure sensors
  • combined loading of an oral appliance for sleep apnea
  • accelerated aging and peel testing of a hospital mattress patch