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所在平台: Udemy |
课程主页: https://www.udemy.com/course/medical-device-software-process-blackbelt/
课程评论：没有评论
课程名称: 医疗设备软件过程黑带 课程概述: 该课程旨在帮助学员掌握医疗设备软件过程的精髓，提供5小时的行业专家培训，内容涵盖安全关键软件原则、FDA设计控制、最新的FDA草案指导文件，以及对IEC 62304和ISO 14971国际标准的深入解析。通过本课程的学习，学员将获得黑带认证，并自信地应对相关挑战。 许多人对医疗设备流程的理解仅限于片段知识，未能将所有环节整合起来。本课程由一位在具有16年经验的专家设计，他在Class III植入医疗器械的实际操作和监管提交方面积累了丰富的实战经验，使得该培训非常独特，能够有效填补学员的知识空白。 课程亮点包括： - 深入解析IEC 62304 - ISO 14971及软件风险管理 - 软件安全分类 - 软件开发生命周期的各个阶段：计划、需求、设计、测试和发布 - 软件维护和配置管理 - 问题解决策略（SiMD和SaMD） - 最新的FDA草案网络安全要求 - 最新的FDA预市场提交要求 - 静态分析和编码标准 学员将获得终身访问权，包括所有讲座的PDF幻灯片、关于医疗设备软件静态分析的白皮书以及62304的核对清单。 邀请您观看11分钟的预览视频，了解更多关于本课程的信息和价值！
DescriptionThe ultimate course for mastery of the medical device software process. This course gives you access to 5 hours of training from an industry expert covering safety critical software principles, FDA design controls, the latest FDA draft guidance documents, and deep insight into IEC 62304 and ISO 14971 international standards. You will graduate a blackbelt and walk away with confidence.Often people have fragments of the medical device process in their head but have never been able to put all of the pieces of the puzzle together. This course is unique and comes to the rescue because the training was put together by a software expert who has done the hands-on work and regulatory submissions for Class III implantable medical devices for 16 years. Why spend thousands of dollars elsewhere? You are invited to spend 11 minutes watching the preview video which will explain why you should take this course!Some HighlightsIEC 62304 in depthISO 14971 and software risk managementSoftware Safety ClassificationAll phases of the software development lifecycle: Planning, Requirements, Design, Testing, and ReleaseSoftware MaintenanceConfiguration ManagementProblem ResolutionSiMD and SaMDLate breaking FDA draft cybersecurity requirementsLate breaking FDA draft premarket submission requirementsStatic AnalysisCoding StandardsLifetime AccessMaterialsPDFs of all slides for all lecturesA white paper on static analysis for medical device software62304 checklists
