Thank you for the kind words and for sharing the video amongst your colleagues.

You are welcome! And thanks for watching and commenting!

Thanks for watching and commenting! All the best to you.

Thank you so much for the kind feedback.

Great to hear that!

Great! Good luck. Please note, there is a risk management plan template available on medicaldevicehq.com. There is a premium template and free one as well. medicaldevicehq.com/store/templates/risk-management-plan-template-medical-device-and-iso-14971/

Glad you like them!

THanks for the feedback.

Thank you for taking the time to comment! And for the "crystal clear precise" description. It is the goal to make these videos just like that.

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Sure, for example urinary tract infection when using a urinary catheter or losing hair during radiation therapy. Oftentimes these risks are side- or after-effects.

@@MedicalDeviceHQ okay...understood....thank you

FMEA is a separate tool if you perform FMEA as defined in for example IEC 60812. And it can be used together with risk management according to ISO 14971. But with an increased understanding of risk management by MDR reviewers, a lot of companies are now running into trouble with an FMEA only approach or FMEA and ISO 14971 combined, because ultimately the probabilities from FMEA will not easily translate into Po. I disagree with the statement that U-FMEA would address risks from normal use. I have so far not seen a use or application FMEA address side- or after-effects, that ISO 14971 would identify.

Thanks for the confidence in my abilities. I fear that the question you are asking cannot easily be answered in a KZfaq comment field. I wish you the best of luck with the assignment, interview and future job! I can tell you one thing though, it is not a risk-benefit analysis you should write. It used to be called that, nowadays, it is a benefit-risk analysis (see both ISO 14971:2019 and the MDR. You can also find guidance documents from the FDA on benefit and risk. You can check out this document for example: www.fda.gov/regulatory-information/search-fda-guidance-documents/benefit-risk-assessment-new-drug-and-biological-products

FMEA is a tool that can be used to support risk assessment as it is defined in ISO 14971. And the purpose is to ensure reliability.

Yes. I just wanted to point out that a FMEA is not a risk assessment. A widely spread misconception.

Is it permissible to cover ISO 14791:2019 Medical Device Risk in its entirety, following DFMEA and PFMEA (AIAG) disciplines, .......provided you also additionally assess Hazards associated with Normal Use Risk,.....such that "Probability of Occurence"(Po) is calculated as prescribed by ISO 14971:2019. Does the "Po" risk have to be transposed for all FMEA line items into the HAzard Traceability Matrix ?

​@@chrismallett9493 thanks for good and relevant questions that quite a few are struggling with when they have submitted their files for review under MDR. The short answer is that there is nothing preventing you from including the kind of risks you would be bringing up in P-FMEA in a hazard traceability matrix. So that can be covered there. The current challenge with FMEA and medical devices (when FMEA is performed in accordance with IEC 60812 or AIAG guidelines) is that you can't easily transfer risks from FMEA to product safety risk management.

I would not advise you to use ALARP at all. Particularly not if you are aiming for the EU market.

@@MedicalDeviceHQ the risk assessment criteria should be defined NACC , ALARP , ACC or NACC , AFAP , ACC which criteria is conform to ISO14971. Please advise.

@@kitsadatanerat4480 the standard as such only say that you need to establish criteria for risk acceptability. Ultimately, you will determine if a risk is acceptable or not, but in order for it to be acceptable, you may have to reduce the risk to a certain magnitude, and/or as far as possible. The latter if you are selling to the EU. So the criteria is up to you depending on jurisdiction. Personally, I would go with determining the magnitude of risk using Acceptable/Unacceptable magnitude and combine that reducing the risk as far as possible if it is for the EU. Both magnitude and AFAP must be met for the risk to be acceptable.

I am not sure I know what you mean by AP?