Having these documents is one thing, making sure that these documents aren't falsified is another. I think, along with ensuring that these documents are present and complete, the FDA most likely also ...

Personally, I think human factors validation should only be re-performed if the user interface has changed with whatever product update has been done. As said in your question, validation is often not...

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, specifically when the DHF is treated as an unchan...

I write down almost everything discussed during meetings. Not all of the information is useful, but doing such both helps me remember the meeting better and provides a basis for writing my weekly plan...

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 approval and approval from animal review boards. I...

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 would be bandaids. I think, when designing a bandaid,...

Generally, clinical research is planned and designed to be as low-risk as possible for patients. Any human testing requires IRB approval and oversight at multiple steps of development. This is necess...

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 occurring before legislation regarding the ownersh...

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, having experience working with people and being comfor...

In all honesty, I think marketing relies heavily on manipulation. Marketing convinces buyers that they need a product and then gives them reasons as to why they should buy it. It plays into their emot...

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 emotions of another person and how to control your own ...

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 is competitive advertising between fast-food compa...

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 continue to make large amounts of money that even a drop...

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 success before applying to a position. Even if the comp...

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 responsibility and communication. That being said, if I...