Paladin Medical can guide you in the optimum selection and testing of biomaterials. There are no “FDA-approved” biomaterials, however, materials can be selected with a higher potential for successful application in medical device design. We know how to optimize existing test data to show suitability for use in medical device applications.
Biocompatibility testing can be expensive and time consuming. We can identify material suppliers who specialize in medical device applications. We can help you qualify alternative vendors and develop validation protocols to demonstrate material equivalence.
ISO 10993-1:2009-biocompatibility standard is only one of many considerations for biomaterials qualification. We ensure you only do the biocompatibility testing that is required and according to protocols that FDA needs for your device. The blanket quotes that many test facilities provide aren’t as helpful as they could be. We can help you interact with the laboratories who conduct the testing to ensure you are only doing the right tests on the right test articles.
The many parts of ISO 10993 play a major factor in the cost of the testing and whether your test results will be accepted by the regulatory authorities. We do more than just coordinate testing. We help you to present the biocompatibility assessment program for your product in the best way to communicate your risk assessment of the materials.
Even when a material supplier provides an FDA Master File (MAF), the information must be presented in a comprehensive fashion. The biocompatibility program must be consistent with the overall device qualification. For additional information please see Qualification Planning.