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所在平台: Udemy |
课程主页: https://www.udemy.com/course/implementing-iec-62304-in-software-as-a-medical-device/
课程评论：没有评论
**课程名称：** 在医疗器械软件中实施IEC 62304 **课程概述：** 本课程旨在帮助学员掌握IEC 62304这一全球医疗器械软件的基准标准，确保医疗器械软件产品符合法规要求，并将安全性和合规性置于首位。学员将学习管理风险、追踪软件变更以及优化开发流程的最佳实践、工具和策略。课程内容适用于软件工程师、质量保证专业人员和项目经理，将赋能学员开发合规、高质量的医疗器械软件，并顺利通过审计。 课程不仅深入讲解IEC 62304，还整合了Atlassian工具（如Confluence和JIRA）在项目管理和文档中的应用。学员将学习如何利用JIRA进行ISO 14971风险管理过程，并确保软件生命周期中的可追溯性。Confluence则将用于创建全面的文档、促进协作以及维护清晰的审计追踪，这些都是法规合规的关键要素。通过实践见解和真实案例，学员将深入了解符合IEC 62304的风险管理技术、文档流程和验证方法。课程结束后，学员将能自信地运用最佳实践，带领团队交付安全、合规的医疗器械软件。
Are you ready to navigate the complex world of medical device software development with confidence? In this course, you'll learn how to successfully implement IEC 62304, the global standard for medical device software, ensuring your products meet regulatory requirements while prioritizing safety and compliance. Discover the best practices, tools, and strategies to manage risk, track software changes, and streamline your development process. Whether you're a software engineer, QA professional, or project manager, this course will equip you with the skills and knowledge to build compliant, high-quality medical software that passes audits with ease.In addition to mastering IEC 62304, this course also integrates the use of Atlassian tools such as Confluence and JIRA, essential for effective project management and documentation. You'll learn how to leverage JIRA for ISO14971 Risk management process, and ensuring traceability throughout the software lifecycle. Confluence will be utilized for creating comprehensive documentation, collaboration, and maintaining a clear audit trail, all vital for regulatory compliance. With practical insights and real-world examples, you'll explore risk management techniques, documentation processes, and verification methods that align with IEC 62304. By the end of this course, you'll confidently lead your team using best practices to deliver safe, compliant medical device software.
