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sts27
@sts27
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Joined: Sep 2, 2020
Last seen: May 2, 2021
Topics: 0 / Replies: 75
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RE: What FDA Looks For In A Design Control System ?

Having these documents is one thing, making sure that these documents aren't falsified is another. I think, along with ensuring that these documents a...

4 years ago
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RE: When is validation is not required?

Personally, I think human factors validation should only be re-performed if the user interface has changed with whatever product update has been done....

4 years ago
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RE: Discussion Topic: Supplemental on DHF and DMR

Unlike in the US, design controls are not required in Europe to release a product. I personally prefer the American method of requiring a DHF and DMF,...

4 years ago
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RE: Minutes for meetings

I write down almost everything discussed during meetings. Not all of the information is useful, but doing such both helps me remember the meeting bett...

4 years ago
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RE: Design Documents in Academia

In all honesty, I think it depends on the nature of your research. If you are working with animals or humans then comparative documents would be IRB a...

4 years ago
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RE: Verification Protocol

As stated in the question: verification is required to ensure that the product works and that it is safe for a patient to use. An example of this w...

4 years ago
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RE: Ethical Issues with Clinical Trials

Generally, clinical research is planned and designed to be as low-risk as possible for patients. Any human testing requires IRB approval and oversight...

4 years ago
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RE: Informed consent: What if Henrietta Lacks checked No for research use?

The interesting thing about Henriatta Lacks case is that it occurred prior to legislation that now exists to inform and protect patients. (As well as ...

4 years ago
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RE: Discussion Topic: Having a "clinical background"

I think that a clinical background is necessary but that the extent of such should vary. While someone may be able to do work in this profession, havi...

4 years ago
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RE: Manipulation or no?

In all honesty, I think marketing relies heavily on manipulation. Marketing convinces buyers that they need a product and then gives them reasons as t...

4 years ago
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RE: Discussion Topic: Emotional Intelligence and its affect on sales

Emotional intelligence is one’s ability to modify their emotions to a scenario (i.e knowing when to be empathetic, knowing how to respond to the emoti...

4 years ago
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RE: Discussion Topic: The Fifth "P" of Marketing

I don't know if I would define it as, "Clever" but I've seen people advertise their products by using another product's viral failure. A good example ...

4 years ago
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RE: Company Ratios

I think when you get into giant companies such as Microsoft the risks behind these, "bad years" and, "bad ratios" reduce. They are so large and contin...

4 years ago
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RE: Accepting job based on company.

I don't think I would necessarily turn down a company based on its type. As you said in your question, you tend to look at financial history and succe...

4 years ago
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RE: Partnership characteristics

In all honesty, I do not know if I would ever enter into a partnership. At this point in my life, I have no interest in organizing that level of respo...

4 years ago
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