Medical Device Courses | kak33 | Mentions https://medicaldevicecourses.com/members/kak33/activity/mentions/ Activity feed mentioning kak33. Fri, 24 Apr 2026 23:19:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 bdf951f10ed8af348a41546de81f9134 jailynp26 replied to the topic "Professions in Academia and the Industry" - https://medicaldevicecourses.com/activity/p/23084/ Sat, 28 Aug 2021 19:30:34 -0400 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»

]]> 4e1b6da2f927198ab42fee7a02428d3e arianaburch replied to the topic "Professions in Academia and the Industry" - https://medicaldevicecourses.com/activity/p/23077/ Fri, 27 Aug 2021 01:01:48 -0400 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»

]]> 15ff19ff4c1c21ed1dff0c1e99276864 thuytienlecao replied to the topic "FDA Considering Updating Quality System Requirements" - https://medicaldevicecourses.com/activity/p/15682/ Wed, 15 May 2019 19:12:50 -0400 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»

]]> 92d972d820e9e0b3657b513f412fc0fd alexandrabuga replied to the topic Process Revalidation in the forum Process Validation and Process Risk https://medicaldevicecourses.com/activity/p/7640/ Sun, 06 May 2018 20:31:27 -0400 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]

]]> 0 f439ef5edff11ee4335358f012986172 thuytienlecao replied to the topic FDA Considering Updating Quality System Requirements in the forum Quality Systems Management https://medicaldevicecourses.com/activity/p/7184/ Mon, 09 Apr 2018 00:39:21 -0400 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]

]]> 0 8161c6bfe08c3aaa472350aa2f952a9d thuytienlecao replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/5348/ Mon, 27 Nov 2017 01:36:57 -0500 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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