Great, presentation and look forward for more videos on Risk Management and Design controls.
@ricardoparales86113 жыл бұрын
Nicely done. Really like the areas to look for team unity at the end.
@MedicalDeviceHQ3 жыл бұрын
Thanks!
@Lowe24765 ай бұрын
Hi, the link for matrix doesn't seem to work, how can I source this template?
@KrishnaChaitanyakc94 жыл бұрын
Very well done.
@markkotfila62864 жыл бұрын
The math at 11:20, 100%*0.1%=0.01% is incorrect.
@203043743 жыл бұрын
You just need to remove the % it is actually 0.01 or 10%
@MedicalDeviceHQ3 жыл бұрын
Yes, you are right. THat one slipped through the cracks. It is updated in the online course though. We will be making an update here too.
@chriskortright80043 жыл бұрын
Question: at 12:21 the example shows P1 as a combination of Hazards A, B and C. These probabilities are multiplied together to get P1 and I interpret this to mean all three hazardous events must occur for the Hazardous situation to occur. But if any one of the 3 event could lead to the hazardous situation on it's own, would P1 then be the sum of event probabilities? Thanks for the video.
@marcmuller3554 жыл бұрын
nice overview. thanks :)
@vijaykumarb22663 жыл бұрын
I am Considering you as my GURU 👌🏻👌🏻
@MedicalDeviceHQ3 жыл бұрын
Thank you Vijay! I appreciate that.
@vsilte24 жыл бұрын
Thanks for sharing! Very interesting topic!
@MedicalDeviceHQ3 жыл бұрын
Glad it was helpful!
@vsilte23 жыл бұрын
@@MedicalDeviceHQ I liked so much that I registered to your course online.
@PMpunk3 жыл бұрын
Any videos/slides on EU MDR/MDD and different phases in them? Great content 👍
@MedicalDeviceHQ3 жыл бұрын
Thanks for the feedback. There aren't any "phases" as such defined in EU MDR. You would have to turn to ISO 13485 that says you need to define the stages of development in your design planning. And what they are and what you call them are up to you!
@ivanguzman64624 жыл бұрын
Common mistake is taking the probability of failure of product design risk tools (e.g. dFMEA) into hazard analysis as a probablity of the harm.
@MedicalDeviceHQ3 жыл бұрын
That is indeed a common mistake.
@delphinemercier53822 жыл бұрын
What is difficult is to evaluate the probability of harm when you don't have data, for example when you want to market a very innovative device. According to ISO 14971, if you don't have data then you should consider a probability of 100%. This could lead to non acceptable individual risk and to non acceptable global risk for device. The consequence is that the device won't be put on the market unless the manufacturer performed large clincal investigation.
@MedicalDeviceHQ2 жыл бұрын
Hi Delphine, sorry if I come across as being picky with words, but the standard tells you to work with Po=100% when it cannot be estimated. But not having data is not the same as it being impossible to estimate. "Expert assessment" is one method to use to estimate the probability. In fact, for most new products, it is the method that is used for most risks. There are however cases where you cannot estimate, for example when software is involved in the foreseeable sequence of events or where the clinical consequence of a specific circumstance cannot be explored due to ethics
@delphinemercier53822 жыл бұрын
@@MedicalDeviceHQ thank you for your answer. I agree that "not having data" = "not possible to estimate". The device I have in mind is a software and you "answer" in the second part of your post. 🙂
@beluhmabasa49444 жыл бұрын
Is Risk Control Measure an integral part of Risk Management Report.? If true. Why has never been a column in risk management report for risk control measure? Thank's
@MedicalDeviceHQ3 жыл бұрын
Risk controls should not be part of the risk management report. The minimum risk management report contents are specified in the ISO 14971: the results of the risk management review, the result of the overall residual risk evaluation and the answer to whether you have processes in place for collection and review of production and post-production information.
@SK-ph7sz3 жыл бұрын
Superb!
@MedicalDeviceHQ3 жыл бұрын
Thank you! Cheers!
@AB-qh3zz4 жыл бұрын
Super
@timithomas61164 жыл бұрын
Nice video
@hamdymonem86163 жыл бұрын
how can i dowload the materix file you mentioned in that vedio
@wilmarkjohnatty4924 Жыл бұрын
YOu cant, the website is desgined just to collect your private information
@ortonormab12610 ай бұрын
Yeah, I know; real late comment: Biggest mistakes is adding numerous of innovative risks and not thinking 1 "are all of these unique risks or can we merge them" 2 "Is this really a probably risk?" Often I see imagninary risks based on really bad behaviour. I mean You can stab someone with a stetoscope. And why add ten different wounds from a sharp edge!