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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iec-62304-medical-devices-software-lifecycle-processes/
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课程名称：IEC 62304 - 医疗器械软件开发与流程 课程概述： IEC 62304标准阐述了医疗器械软件的生命周期要求。该标准描述了多个流程、相互关联的活动和措施，旨在制定与医疗器械软件生命周期相关的国际标准协议。鉴于医疗器械本身是关键产品，因此与之相关的软件也须以严谨和受控的方式进行处理。本课程是医疗器械软件开发的首个互动课程，将帮助您理解如何在整个生命周期内创建和维护安全的软件。您将深入了解重要术语，从而全面参与关于软件安全分类和风险管理的讨论。此外，您还将学习IEC 62304与ISO 14971、ISO 13485、IEC 60601系列等其他标准的关系。 课程特点： - 无限访问课程及其教育材料，学习时可以暂停、重播和多次观看在线讲座，灵活掌握学习进度。 - 了解IEC 62304对软件生命周期开发的要求，无需支付高额的单日课程费用。 - 课程内容包括IEC 62304的基本信息、软件开发流程、安全分类文档、风险管理流程、配置管理和问题解决等。 - 提供练习考试，帮助您评估自己的软件生命周期开发知识。 - 完成所有讲座并通过考试后，将获得成功完成课程的证书。审计人员可能会询问您对IEC 62304的培训情况。 - 课程还提供一月100%无条件退款保证，注册无风险。 - 有讨论论坛可用于提问和报告课程内容问题。 总结： 本课程适合希望深入了解医疗器械软件开发过程的人员。通过学习，您将获得丰富的知识和实用技能，以应对医疗器械软件的开发与管理挑战。
IEC 62304 standard explains the life cycle requirements for medical device software. The different processes, interrelated activities, and measures are described in this standard which develops an international protocol for standard processes related to medical device software life cycle. As the medical device itself is critical product therefore the software associated with it should also be dealt in a serious controlled manner. This course on IEC 62304 is the first interactive course on medical devices software development. It will empower you to understand how to create and maintain safe software for medical devices throughout their life cycles. You will gain a robust understanding of important terminologies to allow you to comprehensively participate in discussions about software safety classifications and software risk management. Along with this, you should also assimilate how IEC 62304 interacts with other standards such as ISO 14971, ISO 13485, IEC 60601 series.You will have unlimited access to the course and its educational materials. The great value within our online courses is that you can pause, re-watch and start again watching online lectures where you actually stopped. You can do this as many times as you like without any limitation whatsoever! This offers you with the comfort to learn what, how, where and when you want.No need to pay thousand dollars for one day awareness course on the design and development of medical devices software. This course will suffice your requirement. You will learn the about this new standard IEC 62304 requirements on software lifecycle development.You will be taught following when you take this course (Course Objectives):Basic information about the IEC 62304Process for Software DevelopmentSafety Classification DocumentationRisk Management ProcessConfiguration ManagementProblem ResolutionFDA, IMDRF Classification for SAMDsCOPYRIGHT NOTICE: Please note that this IEC 62304 standard is IEC copyright protected. A standard copy will NOT be issued with this course. However we offer all our presentation materials in PDFs to be downloaded. You can use the presentation material for your own learning without sharing it to someone else without permission. Practice Exam: The course also comes with a practice exam to let you analyze yourself about the software lifecycle development. Certification: A certificate is also available with this course. Once you complete all lectures and successfully pass the exam, you can have your certificate of successful completion of this course. Auditors can also inquire for your training on the IEC 62304. With this course, obviously you will have a professional course certificate (from Udemy) to show if you are inquired about this during. Therefore you can confidently answer the auditor whether you know IEC 62304 or not.Certificate Issuance Alert from Exoexcellence: Many students have complained that they do not want the new Udemy Certificate (template issued last year). Rather, they wanted the older one. We have communicated their concern to Udemy's management. But please note that is their standard and they are not going to change that for now. So in order to satisfy the need of our students, we have a designed certificate (which is being issued from Exoexcellence Training Resources) which seems satisfactory to our students; raising the concerns. Therefore, now we have a system within the course where you can request a certificate from us after completing the course. One Month Money Back Guarantee: Don't forget, this Course have comes with One Month 100% Money Back Guarantee. This means you have unconditionally no risk when registering to this Course. Ask Questions & Report Complaints: Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course. Take this course: Follow the "Take This Course" Button by clicking at the Top Right Hand Side of the Page. Proceed with the instructions and follow it to register and pay for the course.
