Field Issue Resolution

Material Selection

Design Considerations

Etching and ID Selection

Corrosion Prevention

Lab Equipment in Service

  • AC1 Prevac Autoclave Steris 3013 1/17/2017
  • AC2 Prevac Autoclave Steris 3013 1/17/2017
  • AC3 Autoclave Ritter/Midmark M11 1/17/2017
  • AC5 Autoclave (prevac-mod) Tuttnaur 3870 1/17/2017
  • AC4 Autoclave (prevac-mod) Tuttnaur 1730MK 1/17/2017
  • WD7 Washer/Disinfector Steris 444 1/17/2017
  • US8 Ultrasonic Fisher FS220 1/17/2017
  • US9 Ultrasonic Bulova US9 NA
  • TF1 1000 lb Test Frame Testometric SDL 350 1/17/2017
  • IT1 10000lb Impact Frame Bonesim LLC IT10K 1/17/2016

Do you have new features for your design that requires validation through clinical processing cycles?

New Design

574-551-9814

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?

ANSWERS

What we offer you

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
Reduced Liability
Eliminate Intra-Operative Delays
Uncover Tolerance Issues
Solve Life cycle issues

New Materials