Risk Management Process in Medical Device Biocompatibility (ISO 10993)

Описание: The risk management process in medical device biocompatibility under ISO 10993 involves systematically identifying, evaluating, and mitigating potential biological risks associated with the materials and design of medical devices. This process begins with a thorough biological risk assessment to determine the likelihood of adverse reactions, such as toxicity, irritation, or sensitization, when the device comes into contact with the human body. ISO 10993 emphasizes integrating biocompatibility testing with the broader risk management framework of ISO 14971, ensuring that risks are controlled throughout the device's lifecycle. The process includes selecting appropriate materials, conducting biocompatibility tests, analyzing results, and documenting findings to ensure compliance with regulatory requirements. By following this approach, manufacturers can minimize patient risks, meet safety standards, and enhance the reliability of their medical devices.

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Timecodes
0:00 - Introduction
0:44 - Overview of Risk Management in ISO 10993
1:14 - Risk Assessment
1:50 - Risk Evaluation
2:19 - Biological Evaluation
2:53 - Risk Control and Mitigation
3:19 - Risk Documentation and Review
3:49 - Importance of Risk Management in ISO 10993
4:18 - Conclusion