Reprocessing of single-use medical devices (SUDs) is the practice of inspecting, cleaning, function testing, sterilizing and packaging so that they can be clinically and safely used again. Reprocessing of SUDs is regulated by the FDA. We satisfy all FDA regulatory requirements to reprocess medical devices and ensure that our reprocessed devices are substantially equivalent to original equipment devices.
Implies that two medical devices are equivalent in all characteristics that are of importance to the consumer including patient/physician safety, clinical performance, durability and reliability
Design verification
Design validation
Reverse engineering devices
Cleaning and sterilization
Performance testing
CIS10462 REV A