In my company, the customer needs, business requirements, and test plan are all housed within one document, called the DIOVV (Design Input, Output, Ve...
FDA is looking to make sure that all required elements of a design control system are in place, but more importantly, they are looking to see if the p...
I agree that consistently updating all DHF documents throughout the project is very critical. I have found from my experience that it is very easy to ...
I think I would like working for the sponsor that actually plans out the clinical trial. As an engineer, this role would fit me the best, because it w...
I think this is a very interesting topic that you have raised. However, I do not agree that whoever writes the protocol or pays for the study should o...
I think the use of placebos are important. As Dr. Simon also mentioned in his lecture, the placebo effect is a very real thing, and in order to know h...
I agree with the above posts summarizing what vision and mission statements are, and I would like to add to reshamn's post regarding Stryker. As a Str...
I agree with the above posts regarding the definition of EI. EI is very important for selling. As mentioned in the lecture, building relationships wit...
I have witnessed the fifth "P" of marketing in my company. Rather than the sales reps doing most of the interaction with the surgeons, our marketing d...
The difference between public and private companies is public companies have shares that can be publicly traded on the stock market, whereas the priva...
I researched Amazon and these were my findings as of June 2017: Gross Profit Margin: 38.98% Operating Profit Margin: 2.31% Net Profit Margin: 1.28% R...
I have several suggestions that I believe could improve the relationship between R&D and quality. First, R&D tends to be quite ignorant when i...
In my company, looking at the overall big picture, I would say quality and R&D both have the same end goal. We are devoted to developing quality p...
I agree with the general consensus in the above posts that the quality assurance process and quality control process is very important to ensure a dev...