Applied ISO14971 Medical Device Risk Management (Udemy.com)

The content is very thoughtful and well put together. As well as being very easy to follow along with. The additional resources also provide further information with the topics being covered.

Very good course about medical device risk management. I particularly liked the practical examples provided. However, "only" 4.5 stars as some quiz questions focusing on "which section of the standard refers this, which refers that, etc." were inadequate for this level in my humble opinion.

Even though I have sound knowledge of FMEA I did not know how it differs from Risk Management. But now I know while both ISO 14971 and FMEA contribute to risk management in the medical device industry, ISO 14971 provides a comprehensive framework for managing risks throughout the device's lifecycle, while FMEA is a specific tool for identifying and addressing failure modes during the design and development phase. It seems most organizations often use ISO 14971 as a guiding standard to establish their risk management process and integrate FMEA as a part of that process. Highly recommend this course for someone who is interested in the Medical Device industry jobs.

Great mix of theoretical information and practical execution of risk management and application of the tools. The resources provided are very useful for conducting real world risk management processes

Hoping this gets deeper into the application of risk management. Consider the amount of material in Section 5 compared to Section 6 - Section 6 felt like a sudden stop. Section 5 could be broken down to provide deeper dive into the material that was covered in that section, additional quizzes to really focus on important details.

All the concepts are covered in a thorough manner but at times it feels monotonous. Only slides after slides. I guess taking a medical device and applying every principle from start to finish might make this more visualizable. Although there are use cases in some slides they are not enough. But still, this is a good course.

Yes, is a good match with my doubts... The training is complete and awesome, thanks!!!.. However, I would like to see more about some mistakes that the industry are doing applying the Risk Management. A good example that you have in the training is when is used the "prognosis" as part of the risk evaluation as not a good idea to part. For me, I consider a good example of mistake and I would like to see in the entire training.

Very Good course for giving a general view on how risk analysis management should be performed and all the steps you need to perform and take in consideration for your risk analysis report.

Coursework highlighted important key concepts. Basic understanding of how risk management entails in the industry, as well as examples of how to go about with the same, were clear and understandable. Excellent!

To be frank, the course is not exactly what I was after - however having started it, I felt committed to completing it. The good Doctor, whilst clearly knowing her subject well - could perhaps do with delivering the presentation less 'mechanically'.