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In this tutorial, Helen discusses how to document changes to a medical device and assess their impact on biocompatibility. She explains that any alterations—such as changes in materials, manufacturing processes, supply chain, or packaging—can potentially affect a device's biocompatibility. It is crucial to evaluate the risks introduced by these changes. Helen notes that issues often arise when modifying components of a device, like adding a colorant to enhance visibility, after initial biocompatibility testing has been completed. Proper documentation and risk assessment are essential to ensure safety and compliance in such scenarios.
