American Preclinical Services offers a full biocompatibility testing program. Here at APS, we take the time to understand the specifics of your medical devices and we take a clinically relevant approach to designing and implementing your panel of biocompatibility assays. At APS you benefit from:
Standard & Custom Protocols
APS offers both standard (ISO10993, USP <87>, USP <88> & JMHLW) and custom biocompatibility testing protocols for material and component evaluations, in-vivo and in-vitro testing.
APS offers an array of in-vivo testing. We have both large and small animal capabilities with numerous study designs that can be used for biocompatibility evaluations. Let our experienced staff help you select or design the right in-vivo tests to meet all of your requirements.
In-Vivo Thrombogenicity Testing
Not all in-vivo thrombogenicity studies are created equal.
As the designs of medical devices continue to become more advanced, the overall placement of the device challenges traditional methods. Currently, devices subject to a standard thrombogenicity test are typically placed into the jugular vein with minimal concern as to the impact of blood flow, fit or placement. In reality the traditional design lacks the ability to ensure a proper placement of a device and it is not possible to confirm that proper blood flow has been maintained prior to starting the four-hour indwelling period.
The in-vivo thrombogenicity studies are especially challenging tests for many labs to conduct, given the required equipment, in-house technical expertise and implantation methodologies needed. APS offers you these services, plus superior surgical and interventional deployment techniques using fluoroscopy, which makes the test more reliable and reproducible.
American Preclinical Services has a broad range of in-vitro testing services. We offer multiple methodologies that can be used for the evaluation of biocompatibility, toxicology and lot-release testing. Depending on your regulatory requirements, our in-vitro services offer tests that meet ISO 10993, USP <87>, and JMHLW guidelines.
We are passionate about offering alternative methods that can be used for the evaluation of your product. If you have a specific test methodology that may not be in our current scope, please contact us today to discuss availability and/or a validation plan to meet all of your testing needs.
APS Biocompatibility Testing has not received any reviews.
APS Biocompatibility Testing has not received any endorsements.