Federal Regulations
A Vital Solution
Whether you are a manufacturer licensing a new medical device or managing a required or voluntary recall, navigating the FDA regulations is the most important aspect of your plan. While the regulatory requirements will be different for every situation, one thing is consistent: Using a certified and licensed disposal vendor that provides proper destruction records is a vital part of both the manufacturing and recall strategy.
Licensing Regulations
Medical device manufacturers have challenges getting devices licensed. IoMT Recycling Solutions provides the end-of-life solution that will satisfy the FDAs requirements for manufacturing licenses.
Recall Regulations
Medical device manufacturers are responsible for the removal and destruction of recalled medical devices. We provide full reporting to prove to the FDA that recalled devices were destroyed.