Mentions | Activity | kak33 | Medical Device Courses

jailynp26 replied to the topic "Professions in Academia and the Industry" – 3 years, 7 months ago

Posted by: @kak33 Hey everyone, One of the learning objectives for this week was to get an idea of the different jobs available to Biomedical Engineers. In this week’s lecture, Dr. Simon identified a few positions that are available in… Read more»
arianaburch replied to the topic "Professions in Academia and the Industry" – 3 years, 7 months ago

Posted by: @kak33 Hey everyone, One of the learning objectives for this week was to get an idea of the different jobs available to Biomedical Engineers. In this week’s lecture, Dr. Simon identified a few positions that are available in… Read more»
thuytienlecao replied to the topic "FDA Considering Updating Quality System Requirements" – 5 years, 11 months ago

Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law… Read more»
alexandrabuga replied to the topic Process Revalidation in the forum Process Validation and Process Risk 6 years, 11 months ago

This example is out of the scope of what I encounter with my job responsibilities but I agree with how others have stated that if the equipment is going to be taken a part and moved to a new location and its a more complex situation, that it would require to be re-validated to see if there are any changes with equipment performance. For as @kak33…[Read more]
thuytienlecao replied to the topic FDA Considering Updating Quality System Requirements in the forum Quality Systems Management 7 years ago

Thanks for the article and info @alexandrabuga. I agree that it is logical. And it would make things simpler. Other than the points from @kak33 comment, in comparison with ISO 13485, FDA 21 CFR Part 820 QSR is the law for medical device companies manufacturing and selling products for the US market. So I don’t think QSR would be replaced…[Read more]
thuytienlecao replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies 7 years, 4 months ago

I personally perfer upper management because I tend to look at things in a big picture and for long term processes and I agree with @dag56 and @scott that to be a upper manager, you should have to have certain experience in middle management. Also, I have read the article that @kak33 posted and actually agree with the opinion stated in the article…[Read more]

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