Bringing Specialized Expertise to Medical Device Testing
All medical devices have a thorough set of testing requirements that are enforced by the FDA, China Food and Drug Administration (CFDA), EU Notified Bodies, and other regulatory bodies which is needed to be completed before entering the marketplace.
At TriMetis our goal is to bring your product to market quickly and ethically. We thoroughly assess your product to make sure every aspect has been evaluated, so when you are ready to file, your company will have a smooth filing. We do this by making sure your device meets its regulatory, toxicology, microbiology, chemistry, clinical and quality needs through our unique combination of advising specialists and a hands on approach.
With various and broad testing capabilities, from in-vivo and in-vitro models to analysis tools, our in-house experts comply with regulations to provide our clients with the most accurate results. We have preformed studies in the following fields and are continuously broadening our range.
Based in Memphis, TN is our state-of-the-art GLP ALAAC accredited facility. Our unique and well-equipped facilities can perform all the necessary Preclinical and Biocompatibility tests. To learn more about our facilities, click here.
3D Printers: From Conception to Compatibility Testing
Are you using sterolithography printers to manufacture your device? We can help you identify the right tests you need to conduct for your specific product and help you navigate the regulatory space around this new type of medical device so you can bring your product to market sooner. Click here to contact us.
ISO 10993 Biocompatibility
We conduct all in-vivo biocompatibility testing required to meet ISO 10993 guidelines at our state-of-the art 26,000-square-foot facility in Memphis, Tennessee.
If you choose to have your own employees conduct the testing, we will work with you to provide access to all necessary facilities, support services and training/certification expertise needed to support your team.
Learn more about our Biocompatibility Testing for ISO 10993.
We can work with you to determine what tests are needed to move your product’s development forward. TriMetis has partnered with MRC|X to provide our clients with additional EU and US regulatory assessment, planning and the preparation of submissions and filings as needed. Combined, the partners have over 35 years of experience in the medical device field.
Interested in our surgical models or other medical device testing? Contact Us today.