Скачать или смотреть FMEA: Step-by-Step Guide for Medical Device Risk Management

In this video, we talk about risk management in the medical device industry.

We explain the FMEA method, which stands for Failure Modes and Effects Analysis. This method helps identify, assess, and fix potential problems in medical devices. It looks at how things might go wrong and how serious those problems could be.

The video breaks down FMEA into easy steps, explaining how to define the scope, form a team, identify functions, failure modes, and effects, find causes, evaluate risks, and take mitigation actions.

We also show how to use a tool called Risk Manager Plus inside Jira to manage risks effectively. Watch to learn how to keep medical devices safe and reliable!

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00:00 Introduction to Risk Management in Medical Devices
00:35 Overview of FMEA Methodology
01:50 Steps to Conduct FMEA
05:53 Comparing FMEA and Hazard Analysis
06:21 Implementing FMEA in Jira with Risk Manager Plus
06:54 Example: FMEA for a Glucose Monitoring App
12:56 Documenting and Reporting FMEA
14:58 Conclusion and Final Thoughts

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