The validation of a reusable device is not only required by the FDA but also ensures that your instructions for use are appropriate with your device. C.G. Laboratories, Inc. follows the guidelines of AAMI TIR12 and AAMI TIR30 to validate reusable devices. The validation of a reusable device involves several factors to comply with these guidelines, sterility, cleaning, and repeated use.
Sterilization Validation for Reusable Devicescciadmin2019-05-15T16:50:30+00:00