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?
Shortened Projects Timelines
Eliminate Intra-Operative Delays
Uncover Tolerance Issues
Solve Life cycle issues
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.