Biocompatibility Testing
Biocompatibility testing is a systematic evaluation process used to assess the safety and compatibility of medical devices, materials, or products when they come into contact with the human body. It involves a series of standardized tests to determine if a material causes adverse biological reactions, such as toxicity, irritation, or immune responses. This testing is critical for regulatory approval and ensuring patient safety in healthcare applications.
Developers should learn about biocompatibility testing when working on medical device software, healthcare applications, or regulatory compliance systems, as it ensures products meet safety standards like ISO 10993 and FDA guidelines. It is essential for roles in medical technology, pharmaceuticals, or any field involving human-device interaction to mitigate risks and avoid legal issues. Use cases include developing software for device testing protocols, integrating test data into quality management systems, or designing user interfaces for compliance reporting.