I definitely believe that post market surveillance is extremely important, especially since the FDA requires it. Post market surveillance is extremely important in monitoring how the device is doing w...

I always believe that catching the risks early is more beneficial to creating a safer and more effective product for the intended patients and customers. Finding these possible risks early could lead ...

In my opinion, risk management is especially important during the planning phases of your device. As you plan on the design, the materials and the application, I feel as if it is extremely important t...

I don't truly feel like there could really be design over validation since you would end up with a limited time frame set by your company to get the device into pre-clinical and clinical trials. In my...

When making a device, it is extremely important to have design controls that has been thoroughly researched and has a sufficient amount of evidence to back up its safety and efficiency. When you have ...

In my opinion, the DID is helpful in creating something appealing to the customer visually and allows for the customers needs to be heard in a general sense. This document gives the engineers a genera...

I definitely think that Planning is one of the most important aspects in design control. Without making a proper plan for the creation of your device, it can be very easy to miss deadlines and fall be...

I don't know of any companies that have specifically hid their failures but I know that the FDA is very strict when it comes to this. Negligence is typically not encouraged within the field but there ...

In my opinion, I feel like there could be a variety of reasons that could cause an interim design review meeting. I feel like one of the main reasons a meeting could be called is that there was a desi...

With vaccines today, there are a many factors and variables that researchers have to consider when developing these vaccines and how they are tested in the clinical trials. I am sure that environment ...

With clinical trials, there is always a risk that the patients are willing to take as long as it is explained to them. Within my current job, the clinical trial patients are those with cancer. With th...

If I were to be apart of a clinical trial, the role I would want is to be the clinical research investigator. To me, I would be a good fit for this role because I really like to interact with the pati...

When trying to convince a customer that one product is better than another on the market, I definitely think that there is some persuasion but not specifically manipulation. I don't think that within ...

The internet has definitely changed how to promote products and the range of people that can see it. I think that the internet allows easier access to find more information about a product that is out...

In my opinion, I would say that the most important P would be the product. Without the development of the product or knowing if there is a market for the product, the other Ps couldn't really come int...