1 services found
STEMart Services
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Medical Device Development Service - Reusable Medical Device Validation
A reusable medical device is one intended for repeated use either on the same or different patients, with appropriate cleaning and disinfection or sterilization steps between uses. Reusable medical devices have been widely used in clinical practice for more than a century. Manufacturers of reusable medical devices have the responsibility to provide instructions for device reprocessing such as cleaning, disinfection and sterilization as well as to conduct test to validate these instructions. Testing should not be limited to the efficacy of device reprocessing, functional performance of the medical device at the beginning, middle, and end of a device`s life cycle should be considered as well. Validation data regarding cleaning, disinfection, and sterilization must be included in the 510(k) for submission to the FDA.
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Cleaning Validation Services
Cleaning is defined as removal of soil residues with manual or automated method. It is always the first and necessary step in reprocessing of reusable medical ...