Thanks, your presentation was very informative. (Juarez, Mexico)
@bekindandmerciful51453 ай бұрын
fantastic presentation
@margarettuvelle491710 ай бұрын
This was really great! Very informative and short. I have sent it to several colleagues.
@petersebelius688610 ай бұрын
Thank you for the kind words and for sharing the video amongst your colleagues.
@bujji.kbujjiprem40763 жыл бұрын
Such a clear and great explanation 👏 👏 ...Thank you so much ❤
@MedicalDeviceHQ2 жыл бұрын
You are welcome! And thanks for watching and commenting!
@pennycurtis345 ай бұрын
thank you - great video
@poornanandans98382 жыл бұрын
Very informative & learnt the link between DFMEA & RMF.... Thanks a lot🙏
@MedicalDeviceHQ2 жыл бұрын
Thanks for watching and commenting! All the best to you.
@premasubramanian1486 Жыл бұрын
Your presentation and explanations are very clear,easy to understand...and my doubts were cleared . Thank you sir,
@MedicalDeviceHQ Жыл бұрын
Thank you so much for the kind feedback.
@mohamedhabas7391 Жыл бұрын
Love the risk management concept in medical industry
@MedicalDeviceHQ Жыл бұрын
Great to hear that!
@jhannheras99942 жыл бұрын
Great content! I am doing a risk management plan and this is perfect.
@MedicalDeviceHQ2 жыл бұрын
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/
@carawilcox4 жыл бұрын
Peter, your videos are fabulous. I love your style.
@MedicalDeviceHQ3 жыл бұрын
Glad you like them!
@thimmareddy85413 ай бұрын
It's an informative session. I have a query regarding RPN, why we are not considering the detection measures in risk evaluation
@maikonronsaniborges2 жыл бұрын
Congrats! Your video is very clear and straight to the point!
@MedicalDeviceHQ2 жыл бұрын
THanks for the feedback.
@mohanbhatsingapore49292 жыл бұрын
I really loved this crystal clear precise Presentation. A lot to learn. Thank you Sir
@MedicalDeviceHQ Жыл бұрын
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.
@kdjain2 жыл бұрын
Thank you for posting.
@MedicalDeviceHQ2 жыл бұрын
You're welcome.
@misa143me43 жыл бұрын
Thanks for all the explanation, it was very clear and helpfull.
@MedicalDeviceHQ3 жыл бұрын
Thanks for the kind feedback.
@maharajansasthasundaram22254 жыл бұрын
Thank you
@Mueen5203 жыл бұрын
Thank you. Very informative and organized !
@MedicalDeviceHQ3 жыл бұрын
Glad you enjoyed it!
@1Himalayansoul3 жыл бұрын
Thank You! Very well explained.
@MedicalDeviceHQ3 жыл бұрын
Thanks for the appreciation!
@MatoxBR2 жыл бұрын
Thank you !
@StillNotWanted4 жыл бұрын
Great video
@drvijaymehta482 жыл бұрын
SUPERB EXPLANATION THANKS
@MedicalDeviceHQ2 жыл бұрын
Glad you liked it
@riyagupta72213 жыл бұрын
Could you please give an example of normal use risk to understand more clearly about the difference in FMEA and ISO 14971
@MedicalDeviceHQ3 жыл бұрын
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.
@riyagupta72213 жыл бұрын
@@MedicalDeviceHQ okay...understood....thank you
@Ken0812723 жыл бұрын
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.
@MedicalDeviceHQ3 жыл бұрын
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.
@sn52552 жыл бұрын
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?
@MedicalDeviceHQ2 жыл бұрын
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
@johnnybravo1884 Жыл бұрын
A FMEA is not a risk assessment. It is a method to ensure quality.
@MedicalDeviceHQ Жыл бұрын
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.
@johnnybravo1884 Жыл бұрын
Yes. I just wanted to point out that a FMEA is not a risk assessment. A widely spread misconception.
@chrismallett94932 жыл бұрын
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.
@chrismallett94932 жыл бұрын
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 ?
@MedicalDeviceHQ2 жыл бұрын
@@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.
@kitsadatanerat44803 жыл бұрын
@@MedicalDeviceHQ the risk assessment criteria should be defined NACC , ALARP , ACC or NACC , AFAP , ACC which criteria is conform to ISO14971. Please advise.
@MedicalDeviceHQ3 жыл бұрын
@@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.
@user-ks6eh1gm2s3 жыл бұрын
Does this FMEA need to update to the newest one using AP?