Ready to Verify the Life Cycle of Your Reusable Medical Device?
Providing the robust science you need to validate the useful
life of your reusable medical device.
What We Do
The Importance of Clinical Reprocessing Cycles
Manufacturers of reusable medical devices are responsible for supporting their claims for product reuse. Typically, meeting this responsibility involves developing instructions for preparing the device for reuse, and then conducting tests that validate those instructions. That’s where we come in.
At BoneSim, our Clinical Reprocessing Cycles (CRC) “fatigue” these devices to replicate years of use before they receive further safety testing. Reusable medical devices can be used anywhere between 100-500 times annually. Our testing has uncovered failures in this reprocessing range (and sometimes sooner), prompting design modifications.
New etching methods, manufacturing processes, and new materials need to be thoroughly tested in order to prove they live up to industry standards.
Utilizing our CRC testing provides a technical, unbiased, certified validation so you can be confident your materials and products are able to withstand the rigors of reprocessing.
Our Process
Testing requirements for reusable medical devices have changed dramatically in recent years. Manufacturers must now determine the useful life of their reusable instruments and inform the user of this limit, based on testing data. Additionally, reusable instruments must be preconditioned prior to biosafety testing. Our focus on only high-cycle reprocessing allows you to collect this data on time and on budget.
Planning
Based on your instructions for use (IFU) and protocols, BoneSim will create a customized document (or router) outlining the reprocessing steps we will utilize to achieve your testing goals.
Testing
The number of testing cycles will be set based on your study’s objectives. This will be used to validate the useful life of the device or precondition it for other post-exposure validation testing.
Documentation
Upon completion, you will receive a test certification or technical report documenting the reprocessing steps and number of reprocessing cycles.
Why Us?
Providing the Data You Need
BoneSim delivers a complete package of steps and services. Utilizing our Clinical Reprocessing Cycles (CRC) testing provides a technical, nonbiased, certified validation so you can be confident your materials and products are able to withstand the rigors of reprocessing.
Benefits of Our ISO Accredited Laboratory
Implant Direct
Our Values
Providing the Data You Need
Quality
An ISO accredited laboratory providing high quality clinical reprocessing validations.
Commitment
From proof of design to CAPA verification, we are committed to helping reduce your project timelines.
Experience
Over 50 combined years of experience in testing and evaluation of surgical implants and instruments.