Biocompatibility Testing for Orthopedic Combination Products

    Key Takeaways Start testing early. Begin biocompatibility testing in the design phase to avoid late-stage failures. Plan for complexity. Combination products require integrated validation of device, drug, and packaging. Don’t rely solely on ISO 10993. Include extractables and leachables, cytotoxicity screening, and sterilization testing. Test sterilization impact. EO, gamma, and steam can degrade…