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

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

ANSWERS

What we offer you

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.

New Materials

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.

574-551-9814