In my company, the customer needs, business requirements, and test plan are all housed within one document, called the DIOVV (Design Input, Output, Verification, Validation). the customer needs are li...

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 products that companies are developing are followin...

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 let these things slip, especially in very dynamic ...

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 would be my role to come up with the clinical proto...

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 own any potential IP coming out of the clinical tri...

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 how effective the drug or device is, the investigat...

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 Stryker employee, I agree that I am not aware of a vi...

I agree with the above posts regarding the definition of EI. EI is very important for selling. As mentioned in the lecture, building relationships with the customer is extremely important, and in orde...

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 department is also very much focused on engaging th...

I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on ...

The difference between public and private companies is public companies have shares that can be publicly traded on the stock market, whereas the private companies are not traded publicly on the stock ...

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% ROE: 8.28% ROA: 2.19% ROI: 4.58 % The gross profit m...

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 it comes to what the quality procedures are all abo...

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 products to make healthcare better. However, the me...

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 device will be safe and reliable for the end user. Ho...