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所在平台: Udemy |
课程主页: https://www.udemy.com/course/eu-mdr-regulation-2017745-essential-awareness-exam/
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课程名称：欧盟医疗器械法规2017/745 - 基本意识考试 课程概述：该课程针对欧盟医疗器械法规（MDR）提供了基础知识，并帮助学员自我评估对于新法规的理解。课程旨在帮助希望在欧洲市场销售医疗器械的公司找到具备新法规要求的合格人才。学员完成一次模拟考试后，可查看老师提供的详细解答，进一步加深理解。 考试构成： 在线考试评估将涉及以下领域： - 医疗器械分类 - MDR规则 - 重要定义 - 唯一设备标识符 - EUDAMED - Class I的子分类 - 新法规涵盖的新产品 - 新MDR的实施时间表与公布情况 - MDR与MDD的比较 课程亮点： - 通过考试并达到80%及以上可获证书，证书将于每月末发放，需手动申请并提供资格证明。 - 课程提供的模拟考试帮助学员自评知识掌握情况。 - 鼓励学员不断学习并更新对EU MDR法规的了解，后续将增加案例研究等内容以丰富测试。 额外信息： - 课程注册享受一个月100%的退款保证，零风险体验。 - 学员可在课程讨论区提问或报告问题。 - 点击页面右上角的“参加该课程”按钮，按照指示完成注册与付款。 总之，该课程提供了对欧盟医疗器械法规的深入理解，并为想在医疗器械行业发展的专业人士提供了重要的自我评估工具与学习机会。
Value Addition Alerts: Passing Certification Awarded By InstructorRoad Map for Further LearningCertification: Udemy does not provide certification for exams, they only do in the case of Video Courses. But the great news here is, we have empowered our paid students to have a certificate, once they qualify by 80% in the exams. It is a manual process, in which learners our requested to submit evidence of qualification, and apply for the certificate. The certificates are issued at the end of a month.--------------------------------------------------------------The European Medical Device Regulation (MDR) is a novel collection of regulations that encompasses the manufacturing and distribution of medical devices instruments in Europe, and fulfillment of the regulation will be mandatory for medical device companies after the enforcement for all those companies who want to sell their devices in the markets of European countries. Now the companies need individuals who are well trained and competent regarding the new requirements of EU MDR. The practice exam is made envisioning this issue, to help delegates self assess themselves on essential changes in the new regulations. After the individuals complete one practice test, they can review their answers with the textual explanation provided by the Instructor. -------------------------------------Exam CompositionYou will be assessed when you take this online exam in following areas (Course Objectives):The Classification of Medical DevicesThe Rules of the MDRImportant definitions regarding device exposureUnique Device IdentifierEUDAMEDSub-classification of Class INew Products incorporated under the scope of new MDREnforcement and Publication Timelines of the New MDR MDR Versus MDD-------------------------------------Food for ThoughtBe Familiar with EU MDR Regulation knowledge which you hold...If you think you are an expert in EU MDR Regulation after taking courses on the subject and working with Quality Systems...You need to hold on!Join this exam and self assess yourself!Maybe you need to learn and learn...Or you can prove your knowledge and expertise by successfully completing this exam.Both ways, you are in a win-win situation.-------------------------------------Good news: We will be adding more content for example case studies to practice tests in the future. If you feel that you lack the knowledge you can take EU MDR Regulation courses from Udemy or the instructor to guide you on gaining EU MDR Regulation knowledge.-------------------------------------EU MDR Regulation File: The regulation is published in Official Journal of the European Union. One can view and obtain it online, if you are facing any difficulties, the instructor can help you to have that document. -------------------------------------One Month Money Back Guarantee: Don't forget One Month 100% Money Back Guarantee without inquiry. 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.
