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.
Contact BoneSim Laboratories and we'll create a document outlining the process we will go through with your medical device in order to determine its lifecycle.
Once the lifecycle has been determined, you will receive documentation noting the exact process the device has gone through and how many times. We will clearly state a lifecycle for the device and areas the device failed testing.
All US and European solutions
BoneSim™ Laboratories follows QSR (Quality System Regulation 21 CFR Part 820) and ISO/IEC 17025:2017 standards. All equipment is certified annually to NIST, ANSI/NCSL Z540-1-1994 (R2002) ISO/IEC 17025:2017.
Copyright © 2021 BoneSim Laboratories CRC™ - All Rights Reserved.