Field Issue Resolution
Etching and ID Selection
Lab Equipment in Service
Do you have new features for your design that requires validation through clinical processing cycles?
BoneSim™ Laboratories follows QSR (Quality System Regulation 21 CFR Part 820) and ISO 13485:2003 standards.
All equipment is certified annually to NIST, ANSI/NCSL Z540-1:1994 ISO/IEC 17025:2005.
Do you have new materials that requires validation through clinical processing cycles?
CRC™(Clinical Reprocessing Cycles)
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.
Shortened Projects Timelines
Eliminate Intra-Operative Delays
Uncover Tolerance Issues
Solve Life cycle issues