Risk management for medical devices and ISO 14971 - Online introductory course

Your presentation and explanations are very clear,easy to understand...and my doubts were cleared . Thank you sir,

A FMEA is not a risk assessment. It is a method to ensure quality.

Love the risk management concept in medical industry

Thank you !

I really loved this crystal clear precise Presentation. A lot to learn. Thank you Sir

Thank you for posting.

Very informative & learnt the link between DFMEA & RMF.... Thanks a lot🙏

Hello! I have a writing test for an interview. I have no experience in medical writing. They want me to write a risk-benefit-analysis and provided me with articles.

I would really appreciate it if you can tell me how can I do that? And do I need statistical analysis?

SUPERB EXPLANATION THANKS

Great content! I am doing a risk management plan and this is perfect.

How is the traditional Process FMEA addressed by the Hazard Traceability Matrix, with respect to ensuring each process step in the manufacturing process has its risk of manufacturing a product out of specification correctly assessed ?
Can the same Hazard Traceability Matrix be used for PFMEA as described in the video ? ........or would the headers be slightly different to capture PFMEA risk ?
Do you have a template available ?
Can the Same Hazard Traceability Matrix be used to replace an existing Design FMEA ? ......or would the header be slightly different to capture DFMEA risk ?
Best Regards, Chris.

Congrats! Your video is very clear and straight to the point!

Thank You! Very well explained.

The presenter showing FMEA as a separate tool from ISO14971. Many companies reliably use FMEA as one of the elements of RM to meet 14971. The FMEA is adopted to cover risk identification, quantification and evaluation. Also there are different types of FMEA’s and some do cover the Risks associated with the normal use of the product ( I.e. use-FMEA). In addition, FMEA are beneficial in the development of control plans and identifying Essential Design Outputs. The point is that FMEA’s has advantages other tools do not.

Could you please give an example of normal use risk to understand more clearly about the difference in FMEA and ISO 14971

Such a clear and great explanation 👏 👏 ...Thank you so much ❤

Thanks for all the explanation, it was very clear and helpfull.

Thank you. Very informative and organized !

Does this FMEA need to update to the newest one using AP?

Peter, your videos are fabulous. I love your style.

If​ risk​ evaluation​ ALARP​ need​ ​ reduce to​ ACC​ only​ or not? Please advise

Great video

Thank you