Informative talk. Defining safety as freedom from unacceptable risk is if anything clearly clever. It begs the questions: what is risk? what is ‘freedom from’ and how would you quantify this? and what is unacceptable? a threshold value? a qualitative assessment? etc etc
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/
Thanks for the forecast! I have a quick question: I have a SafePal wallet with USDT, and I have the seed phrase. (behave today finger ski upon boy assault summer exhaust beauty stereo over). What's the best way to send them to Binance?
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.
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?
Thanks for the confidence in my abilities. I fear that the question you are asking cannot easily be answered in a RUclips 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
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.
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.
@@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.
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.
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.
![Felix "Unfair" | [Stray Kids : SKZ-PLAYER]](http://i.ytimg.com/vi/Oswujxm2Ag0/mqdefault.jpg)
Informative talk.
Defining safety as freedom from unacceptable risk is if anything clearly clever. It begs the questions: what is risk? what is ‘freedom from’ and how would you quantify this? and what is unacceptable? a threshold value? a qualitative assessment? etc etc
Thanks, your presentation was very informative. (Juarez, Mexico)
thank you - great video
fantastic presentation
Love the risk management concept in medical industry
Great to hear that!
This was really great! Very informative and short. I have sent it to several colleagues.
Thank you for the kind words and for sharing the video amongst your colleagues.
It's an informative session. I have a query regarding RPN, why we are not considering the detection measures in risk evaluation
Your presentation and explanations are very clear,easy to understand...and my doubts were cleared . Thank you sir,
Thank you so much for the kind feedback.
Such a clear and great explanation 👏 👏 ...Thank you so much ❤
You are welcome! And thanks for watching and commenting!
Great content! I am doing a risk management plan and this is perfect.
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/
Thanks for the forecast! I have a quick question: I have a SafePal wallet with USDT, and I have the seed phrase. (behave today finger ski upon boy assault summer exhaust beauty stereo over). What's the best way to send them to Binance?
Very informative & learnt the link between DFMEA & RMF.... Thanks a lot🙏
Thanks for watching and commenting! All the best to you.
Could you please give an example of normal use risk to understand more clearly about the difference in FMEA and ISO 14971
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
Peter, your videos are fabulous. I love your style.
Glad you like them!
I really loved this crystal clear precise Presentation. A lot to learn. Thank you Sir
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.
Congrats! Your video is very clear and straight to the point!
THanks for the feedback.
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?
Thanks for the confidence in my abilities. I fear that the question you are asking cannot easily be answered in a RUclips 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
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.
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.
Thanks for all the explanation, it was very clear and helpfull.
Thanks for the kind feedback.
Thank you for posting.
You're welcome.
Thank you. Very informative and organized !
Glad you enjoyed it!
Thank You! Very well explained.
Thanks for the appreciation!
Does this FMEA need to update to the newest one using AP?
I am not sure I know what you mean by AP?
If risk evaluation ALARP need reduce to ACC only or not? Please advise
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.
Great video
A FMEA is not a risk assessment. It is a method to ensure quality.
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.
SUPERB EXPLANATION THANKS
Glad you liked it
Thank you !
Thank you
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.
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.