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所在平台: Udemy |
课程主页: https://www.udemy.com/course/artificial-intelligence-risk-management-for-medical-device/
课程评论：没有评论
课程名称：将ISO 14971风险管理应用于医疗设备 课程概述：本课程深入培训AAMI/BSI TR 34971和ISO 14971标准在基于AI的医疗设备中风险管理的应用。学习者将探索这些全球认可的框架如何确保产品生命周期中的安全、合规性和质量。课程特别关注AI特有的挑战，如算法偏见、模型漂移和数据完整性，帮助参与者获得在医疗保健中减轻与AI技术相关风险的宝贵见解。 课程内容涵盖了识别危害、风险分析、风险控制及残余风险评估等基本主题。同时，学习者将理解如何将风险管理实践整合到医疗设备开发和上市后监管阶段。课程通过实际案例和示例，说明AI驱动的医疗设备如何满足监管要求，同时保持高水平的性能和安全性。课程还提供了多个模板，供学习者应用以简化风险管理流程。 完成课程后，学习者将掌握有效实施符合ISO 14971和AAMI/BSI TR 34971的风险管理流程的知识，确保他们的基于AI的设备符合国际标准和规定。本课程非常适合参与医疗设备行业产品开发、质量保证和监管事务的专业人士，以及AI系统开发者。
This course provides in-depth training on the application of AAMI/BSI TR 34971 and ISO 14971 standards for managing risks in AI-based medical devices. Learners will explore how these globally recognized frameworks ensure safety, compliance, and quality throughout the product lifecycle. By focusing on AI-specific challenges-such as algorithm bias, model drift, and data integrity-participants will gain valuable insights into mitigating risks associated with AI technologies in healthcare.The course covers essential topics including hazard identification, risk analysis, risk control, and the evaluation of residual risks. Additionally, learners will understand how to integrate risk management practices into both the development and post-market surveillance phases of medical device deployment.Practical examples and case studies are used to illustrate how AI-driven medical devices can meet regulatory requirements while maintaining high levels of performance and safety. The course includes several templates that learners can apply to streamline the risk management process. By the end of the course, learners will have the knowledge to effectively implement risk management processes that align with ISO 14971 and AAMI/BSI TR 34971, ensuring that their AI-based devices are compliant with international standards and regulations. This course is ideal for professionals involved in product development, quality assurance, and regulatory affairs in the medical device industry, as well as AI system developers.
