ISO 14971:2019 风险管理:要求On-demand互动点播课

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