在不断变化的环境中掌握生物相容性测试

Sponsored byDanese Joiner-Fox, Ph.D., StrykerHelin Räägel, Ph.D., Nelson LaboratoriesSteph Street, Ph.D., MedtronicEd Margerrison, Ph.D., CDRH, U.S. FDAMastering Biocompatibility Testing in a Shifting LandscapeMastering Biocompatibility Testing in a Shifting Landscape: Setting the Stage – Industry Perspective Danese Joiner-FoxSenior Manager Regulatory AffairsStryker Sustainability Solutions Conducting Biocompatibility Assessments Can be Challenging Time MoneySample(Devices) Additional Challenges •Addressing all recommended endpoints in the FDA biocompatibility guidance document•Addressing the biocompatibility of instruments•Sometimes the focus is on implants•Inability to compare representative samples that are used for physical testing to the final finished deviceUse of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"Additional Challenges •Assessments that focus only on the biocompatibility