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We're not all mugs

Hi Naveen, I always love to watch you ❤. This video specially sparked me to look at 05 year back. When I have started to manage PMS activities. Thank You

5:24 "(...)Certain sequence of events may not have a very high exposure for the patient and as a result the harm may be of low severity(...)" I don't agree with this statement. I think you meant "risk" instead of "severity". The severity is not affected by the sequence of events and hazardous situation, however risk is.

'Promo SM'

Good evening sir

What FDA worksheet was shared?

Very complete Thanks

Really like the presentation and efforts to team and share us knowledge, benchmarking benefits analysis and linkage with risk level can be studied like we can apply that mechanism to all devices if possible

If only people with symptoms test themselves, the true positive rate is probably better than if a group of asymptomatic people are screened, prior to flying for example.

I'm sorry, someone here has no idea what open source means. It does NOT mean that anyone can access your data. Open Source means, making the source code available, not personal data. The questions were not about open source, they were about granting access to 1. your QMS (which if it's just SOPs etc. should not have patient data) 2. complaints 3. to do some risk assessment: 1. not a problem if your qms doesn't contain personal data or PHI, 2. I would not do it as complaints might be hard to clean from personal data automatically, and 3. was too unspecific and also unrealistic. AI is not magic. Risk assessment is highly subjective even when incorporating plenty of pms data. I assume he meant going through PMS information automatically. And again, if you have audited the open source AI you want to use for that (assuming that's what "open source" here hinted at), and that AI does not transmit anything anywhere out of your control, then I don't see a problem. Algorithms != Data. This kind of risk assessment really should be done with subject matter experts. The auditors also have a team with technical experience, that will go through your technical file way before the actual audit happens.

Hi do u provide courses for Risk plsease

I like it. ❤

Hi Naveen, amazing lecture once again. Shree Koushik mentioned something about P1 and P2 and said that the annex H actually talks about how P2 may not be necessarily required for IVD. Is that really the case? My first look into annex H did not tap this information.

Could you provide the link Ed mentioned of the Linkedin,please?

+1 on the flow chart comment, i hope 18969 gets some traction soon as i struggle with the same issues at the moment...

Hello Sir Is Severity qualitative or quantitative? And How exactly severity calculated and arrived to numeric value?

So, that means FDA would allow us to take the risk of killling 1 in 1000 if others lose significant weights ? Actually, who and when will decide that numbers? Is it kind of estimation before market, and live data at post-market? If more people get injured or damaged, then we should reconsider the risk analysis again. By the way, thank you so much for all of your videos :)

Great session Naveen! Thank you for having me on. ⭐

What about how to use it and no phone around. Dose it need an intent?

just making sure, you have to use the app to use the test correct?

How do i do this w/o a phone?

Very stupid design. Can not be used on the easy way. Do not buy.

In case anyone needs to use this test in the future, be aware that it is single use only. And if for some wile reason the app crashes or the result is "Invalid", try tearing the cartridge down. The kit is way too expensive to trash it and try again. Use a flat head screwdriver to split it open and look at the test strip inside to see if there is a line in the test area and that the control line has worked. Twice ive had this test brand give me invalid results. No other interruptions occured, or time problems. When taken apart, test strip appears to be fine and in working order. Therefore, if you have these test kits for some reason and theyre being ridiculous on the app, tear them down and take a look at the test strip yourself. I received multiple boxes of these from the USPS, for visually impaired. I do not know how these could be beneficial to visially impaired since there are more steps in this method than others, and requires reading on a cell phone. There is a brand of strep tests that I recall using many years ago that has large plus signs that pop up, lateral flow kits, and I would assume the same could be made for covid using similar kits. Would be much better than this kit for visually impaired.

as per ISO 24971 if probability of hazardous situation leading to harm is very low or high it can be taken as 1 but is this approach is correct it is question for you sir Thank you very much My name is Chinmay Sapre I work as a quality engineer

Hello doctor, How is it possible that a testing machine at work tells a person that they tested positive but the same person, on the same day takes home Antigen tests five times in a row and from five different brands and has a result of NEGATIVE and then also goes to take a PCR test and test result is also NEGATIVE too. What can cause a work place machine to give someone a FALSE POSITIVE test result.?

Hi Dr Agarwal. I have a cough/sore throat. I tested positive with a very faint line on one antigen test, but negative on two others. The next day I tested negative on two additional tests. Should I consider the one positve test as being accurate?

Hello Naveen thank you for Video on Risk Analysis and question is any case study or information on risk analysis, how to identify the risk associated to Medical device...some glance on it..

no reason i need a fucking bluetooth device and an app for a home test. just crack the device and take the stick out and rub it on there for anyone wondering how to do this test

I agree with your examples. However ISO 14971:2019 Table C.3 provides examples of Hazardous Situations that encroach into the Harms territory. Their example of a Biological Hazard: Sequence of events: 1) Inadequate decontamination of anaesthesia tubing, 2) Contaminated tubing used during anaesthesia Hazardous situation: Bacteria released into airway of patient during anaesthesia Harm: bacterial infection If I understand your examples, it would be written as: Sequence of events: Inadequate decontamination of anaesthesia tubing, Hazardous situation: Contaminated tubing used during anaesthesia Harm: Bacteria released into airway of patient during anaesthesia leading to bacterial infection I would argue that the Hazardous Situation exists as soon as the contaminated tubing is available for use, without even coming into contact with a patient. Same logic for an exposed live wire or a wet floor. Thoughts?

I am trying to understand the standard after 4 years of it's revision. The insights in the video are very much helpful. I have watched other videos on let's talk risk and I find them interesting because of the practical approaches you use to explain the concepts. Please keep posting such useful information. Looking forward to much more concepts in medical device industry. Thank you for sharing your knowledge.

I missed the following information on my antibody test. Sars cov-2 IgG AB normail value Neg 23.0 AU/ml Thanks

I do not know if the following comment was submitted. Will try again. On April, 2021 I had my second Pfizer covid shot. I was age 89. The next day I went into heart failure with no apparent hope of recovery. It took many weeks to recover to a point where my health was better thanks to great care from doctors. On June 12th 2023, I had what seemed to be Covid. The test kits provided by the government tested negative. I was sick with the usual runny nose, continuous cough, weakness, etc lasting 5 weeks which did seem to be Covid despite the negative test result. We recently learned a daughter did have Covid during a visit in May/June although she had no indications. Surprisingly, an antibody high positive test result for her did show a definite recent case of Covid in the prior 4 to 6 weeks. To possibly confirm my case, I had an antibody test done. It is a positive 800. It was performed using DiaSorin Liaison (R) Sars-Cov-2 Trimeric S lgG assay. Can you please tell if this indicates my recent sickness was Covid, perhaps a variant? To my knowledge I have not had any illness between my last vaccine in 2021 and this recent illness in June. Please advise and thanks.

Many thanks sir

Great presentation! Thank you for your sharing!

i wonder during the analyzing time, if the phone turns black, what would happen. usually by default the phone is set to turn black in 30 sec or 1 min if no activity....

Hi sir, i want to know the risk management of medical device Percutaneous coronary interventions (PCI)

Brilliant, your ifu should have usability assessments as its an interface.

Hello sir.....your sessions are very informative Can you please tell us how to calculate the risk?

Hi! I have a question. what happened if the fluid dropped on my phone, then my mom touched my phone, and she didn’t washed her hands after she touched my phone, then she touch all over the house, will this be danger? I heared the chemicals in the fluid is not safe, I am so anxious right now.

video is good, but, what a dumb test it is !!!

Ellume brand is stupid. What a waste!!! Avoid Ellume Brand and the company!

Where is the data for effectiveness against omicron?

great video, unnecessarily complex device compared to all other ones. what a waste of electronics

Thank you so much for what you do!

Stay away! It's needlessly complicated and expensive. You need a smartphone and an app. I strongly suspect it data mines. Hard pass.

2 things to share. The internals is a sensor looking for a line. The app may fail and then never be able to give you a reading but you can try to redo the test if you break open the case, take the test strip and do the same thing. The process is pretty similar to a pregnancy test. 1st line for control, 2nd is for positive or negative. The second thing is cr2032. Its a very common battery for garage door openers, some watches, gameboy cartridges, or just general electronics. Reduce e waste by salvaging these barely used batteries.

Thank you Naveen ji for sharing it with crisp & clear ...quite helpful

This test is awful, I do not want to download any apps nor give my personal info. I just want the simple test that I can read myself in minutes, leave my phone out of it.

Dont forget to take out the battery and use it for something else like tea light candles or your tamagatchi.

Thank you stay safe and healthy 🧘‍♀️