What is ISO 10993
The U.S. Food and Drug Administration and international regulatory bodies alike (China Food and Drug Administration (CFDA), EU Notified Bodies, etc.), call for medical devices to be tested in accordance with the International Organization for Standardization (ISO) 10993 guidelines which determine the product’s potential toxicity.
How can TriMetis help?
Our consulting process starts out with a comprehensive risk assessment to determine which of these tests need to be performed on your unique product. We offer this service for free if you continue in partnership with our team for the recommended testing protocols. From our experience this assessment is a vital step in your product’s innovation pathway and will save your company time and money.
Click here to download our biocompatibility matrix for an overview of the ISO testing guidelines.
Once you are ready to conduct the necessary tests, TriMetis moves forward with protocol development and manages the in-vitro requirements and conducts 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 your company prefers a more hands on approach in implementing the protocols, we will work with your employees to provide access to all necessary facilities, support services and training/certification needed.