Frequently Asked Questions

We help manufacturers determine how many times their reusable instruments can be cleaned and sterilized before they are no longer usable. We can also help you expeditiously precondition your device to the end of its useful life for subsequent validation testing. BoneSim can provide the robust science you need to verify the useful life of your device without overburdening your development process.

BoneSim Laboratories has a battery of autoclaves, washers, disinfectors, and sonic washers to replicate the conditions that your device will experience in the reprocessing environment in the field. In addition, BoneSim provides functional testing that is agreed, between you and us, to simulate the forces that your device will experience in the field during relevant procedures. We provide a high volume of cycles through these machines and functional tests to simulate hundreds of uses and reprocessing to determine how long your device will be usable in the field.

BoneSim does not provide cleaning validations, sterilization validations, or biocompatibility assessments, but we can help you find a provider that we work with to complete these and other similar tests for you.

We provide pre-test, interim, and post-test functional testing to assess the impact of reprocessing exposure, including:

• Assembly/Disassembly
• Mating Component Checks
• Actuating Moving Parts
• Powering Devices On/Off
• QR Code Scanning Checks
• Instrument Use

We can provide the following functional tests that are not within the scope of our ISO accreditation. The testing is conducted by fully qualified personnel using calibrated equipment but the results provided are non-accredited:

• Dimensional Checks
• Impact Tests
• Tension/Compression Tests

We are able to ship directly to a third-party lab for add-on services such as cleaning validations, sterilization validations, or biocompatibility assessment testing when required.

We have customers all over the world. For customers in Northern Indiana and Southern Michigan, we also have a courier service to reduce shipping costs and time whenever possible.

Most of our clients are original equipment manufacturers (OEMs) of reusable medical devices. Whether a startup or large established organization, BoneSim can provide high volume efficient reprocessing cycles to provide evidence of your device’s reuse life to address design challenges or in-field issues.

BoneSim is ISO 17025:2017 accredited for conducting clinical reprocessing studies. We have more than 50 years of combined experience in the field of medical devices and more than a decade of experience in Clinical Reprocessing Cycle testing and the evaluation of surgical instruments.

A great place to start is to complete our “Request A Quote” form on the website. Once you supply us with the objectives and details of your project, we will conduct 1-2 phone calls to resolve any questions and to clarify test parameters for our team. We will then provide you with a quote for our services.

You can also email at support@bonesim.com or reach out at (574)-551-9814 any time for project inquiries or general questions.