ISO 14971:2019 风险管理：要求On-demand互动点播课

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这门强化课程使学员进一步了解ISO 14971:2019标准对制造医疗器械时的决策过程的影响。

它帮助医疗器械专业人士了解ISO 14971:2019标准如何改善他们的业务和风险管理工作。

本课程旨在让您了解ISO 14971:2019标准以及它对医疗器械的设计、开发、制造和生命周期的影响。它还将为医疗器械制造商提供ISO 14971:2019与ISO 13485:2016标准和MDR 2017/745的相关知识。

This on-demand intensive course enables greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices.

It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.

This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing, and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745. Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course.

课程收益How will I benefit?

定义风险管理的术语
在你的组织内应用风险管理原则
识别ISO 14971:2019、ISO 13485:2016、MDR 2017/745和IVDR 2017/746之间的联系

Identify the key requirements of ISO 14971:2019
Interpret and communicate the key requirements and expectations of ISO 14971:2019 to your organization
Gain knowledge of how ISO 14971:2019 links to ISO 13485 and the regulations; MDR 2017/745 and IVDR 2017/746

- 定义风险管理的术语
- 解释风险管理与产品生命周期的关系
- 概述风险管理过程的各个阶段
- 定义风险管理过程中的关键交付物
- 在你的组织内应用风险管理原则
- 识别ISO 14971:2019、ISO 13485:2016、MDR 2017/745和IVDR 2017/746之间的联系
- Define risk management terminology
- Explain how risk management relates to the product lifecycle
- Outline the stages of the risk management process
- Define the key deliverables of the risk management process
- Apply risk management principles within your organization
- Identify the links between ISO 14971:2019, ISO 13485:2016, MDR 2017/745 and the IVDR 2017/746
参与医疗器械设计、开发和制造的QA/监管/工程/制造角色

QA/Regulatory/Engineering/Manufacturing role involved in medical device design, development, and manufacturing
你可以在适合自己的时间学习，从任何支持互联网的设备上24/7访问该课程。
- This is an online, interactive eLearning course
- You’ll have access to the course for 12 months

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