Katie Bell Email & Phone Number

• Collaborate with associates of diverse technical backgrounds and partner with project team engineers, quality engineering, manufacturing, packaging, sterilization, and regulatory Subject Matter Experts to achieve desired project outcomes• Compile/write biocompatibility strategies, evaluations, and process approval memos• Act as study sponsor for testing conducted at external testing laboratories, especially NVR/FTIR, ICP/MS, and cytotoxicity testing • Ensure all testing meets ISO, FDA, CDRH, and GLP requirements• Review engineering protocols and external lab protocols and reports for completeness and accuracy • Assess and document test results, primarily for NVR/FTIR, ICP/MS, and cytotoxicity testing • Execute biological safety evaluations of medical devices according to ISO 10993, including gap assessment activities• Understand and identify possible gaps for ISO 10993-1 and supporting ISO 10993 testing where needed• Work with site staff to locate and review existing product documentation in respect to device biocompatibility, manufacturing, packaging, and sterilization• Ensure documentation is accurate, consistent and on the current template revision

• Review memos for biocompatibility strategies, material approvals, and device approvals; Compile data from testing or other evaluation/approval documentation for company databases and archives• Review device bill of materials, engineering drawings, and supplier documentation for accuracy and transcription to new documents, for material and manufacturing process information and identification of potential biocompatibility impact• Prepare biocompatibility samples to be sent for testing by providing guidance on sample collection, handling, packaging, and inspection• Orchestrate testing of biocompatibility samples with contract laboratories, determine sample requirements, and review and provide feedback on engineering studies• Verify accuracy of test-sample information on analytical test reports and the presentation of the data; verify risk assessment calculations for Toxicologists• Maintain and track biocompatibility test samples through progression of testing and to final off-site storage and create and manage documentation for vital records

Cincinnati, Oh

Cincinnati, Ohio

Cincinnati, Oh

Cincinnati, Oh

Cincinnati, Oh

Paleoethnobotanical Research

West Chester, Oh