BoneSim™ Laboratories provides medical device life cycle testing for R&D purposes. Our Clinical Reprocessing Cycles, or CRC™, including surgical instrument life cycle testing can help device producers bring their product to market with more efficiency and with more confidence in the end product. Utilizing our CRC™ services allows for a technical, non-biased, certified validation in which the end user will be provided with the certificate and corresponding technical document(s).
Functional and assembly testing at intervals also provided.
The FDA notes that labels on reusable medical devices should either tell users how many times the device can be reused or inform the user how to tell when the device has reached the end of its lifecycle.
Do you have new materials or medical devices that require validation through clinical reprocessing cycles?
Do you have new features or processes for your design that requires validation through clinical processing cycles?
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