Handling Unexpected Biocompatibility Test Results in Medical Device Development

Getting unexpected or failing test results for any biocompatibility test can feel like the end of the line for a medical device. As a vital step in device development, biocompatibility testing has a major effect on the approval process timeline. This 10-minute presentation sheds light on the bleak consequences of unexpected biocompatibility test results. It outlines several questions designers should ask as well as answer throughout an investigation to understand the results and what they mean for patient safety and regulatory compliance.