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所在平台: Udemy |
课程主页: https://www.udemy.com/course/iso-134852016-design-and-development-of-medical-devices/
课程评论：没有评论
课程名称：ISO 13485:2016 - 医疗器械的设计与开发 课程概览： 本课程为医疗器械设计与开发提供高质量的培训，依据ISO 13485:2016标准及最佳行业实践。ISO 13485:2016是针对医疗器械制造商和供应商的质量管理体系国际标准。该标准旨在帮助企业满足监管要求。医疗器械行业的设计与开发过程复杂，涉及多个角色和阶段，因此本课程旨在简化该过程的理解。课程中讲解了基于ISO 13485:2016要求的新兴模型，这一独特的教学方法由课程讲师独立开发。 学习目标： - 介绍ISO 13485:2016 - FDA瀑布模型的设计与开发 - 设计与开发的新兴模型 - 设计与开发计划 - 设计与开发程序 - 设计与开发输入 - 设计与开发输出 - 设计与开发审查 - 设计与开发验证 - 设计与开发确认 - 设计与开发转移 - 设计与开发变更 - 设计与开发文档 - ISO 13485对设计与开发的要求 课程特色： - 不需支付高额费用即可获得医疗器械设计与开发的全面知识。 - 提供课程专属的两份免费资源，包括课程幻灯片演示和新兴设计与开发模型的PDF文件。 - 课程设有模拟考试，帮助学员评估学习效果。 - 完成所有课程内容并通过考试后将获得证书。 - 一个月无条件退款保证，注册无风险。 证书及其他信息： 课程中提供的证书由Exoexcellence培训资源颁发，满足学生对证书样式的需求。课程讨论区可用于提问和反馈问题。 报名方式： 请点击页面右上方的“报名此课程”按钮，并按照指导完成注册与付款。
This is a premium quality course on design and development of medical devices as per ISO 13485:2016 and best industrial practices. ISO 13485:2016 is the international standard for the quality management system of medical devices' manufacturers and suppliers. The standard name is also entitled with an additive expression "For Regulatory Purposes". It means the standard is designed in a way to help companies in meeting the regulatory requirements as well.Design and development in a quality management system is the most complex part. Similarly in the medical devices sector, design and development is a complex process which involves various roles and phases. Hence this course is engineered to make the process of design and development of medical devices easier for you to understand. The rising model based on ISO 13485:2016 requirements of design and development is only taught in this course. Rising model is developed by the instructor of this course and is therefore unique way of explaining the ISO 13485 requirements on design and development. What you will learn when you take this online course (Course Objectives):Introduction to ISO 13485:2016FDA Waterfall Model for Design and DevelopmentRising Model for Design and DevelopmentDesign and Development Planning Design and Development ProcedureDesign and Development Inputs Design and Development OutputsDesign and Development ReviewDesign and Development VerificationDesign and Development ValidationDesign and Development TransferDesign and Development ChangesDesign and Development FilesISO 13485 Requirements on Design and DevelopmentNo need to pay thousand dollars for one day awareness course on the design and development of medical devices. This course will suffice your requirement. You will learn the about this new standard ISO 13485:2016 requirements on design and development.NOTICE: Please note that this ISO 13485:2016 standard is ISO copyright protected. A standard copy will NOT be issued with this course. Amazing Offer - Resource Materials: There are two free resources which are exclusively given in this courses.One PDF file for Slides Presentation: All slides of this course is given with first lecture of this course.One PDF file for rising model of design and development: The unique Rising model based on ISO 13485:2016 requirements on design and development is available with the second lecture.Practice Exam: The course also comes with a practice exam to let you analyze yourself about the awareness of design and development taught in this course. 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.One Month Money Back Guarantee: Don't forget, this Course have without inquiry, One Month 100% Money Back Guarantee. This means you have unconditionally no risk when registering to this Course. 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. 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.
