I believe that noticing the risks early would be beneficial in the cost/benefit analysis. Adding a warning/label would save the company in legal battles but could backfire on them when the damage is t...

I believe that acceptable would be considered as a low severity of a risk. For example, if a bandage would not work as intended, i.e. a lack of adhesion, then that would be something that can be an ai...

An example of a hazard would be a malfunctioning Bunson burner in the chemical lab. Unfortunately, during the ignition process, the collar is unable to be adjusted to control the air flow. The hazardo...

I think that devices that aren't going to be invasive to the user, Design Verification and Validation would be enough. I would say for Clinical Trials are unavoidable though they would be implemented ...

I don't have any industry experience, but I can see how verification and validation can be mistaken for each other. Validation ensures that a certain criterion is reached. That includes compiling any ...

I believe that meeting minutes is essential to the production process. Not only does it keep a detailed account of what one has to do, it also aids others in not repeating the same mistakes. It can al...

I believe that there are not any disadvantages to the DSD and DID documents. Both complement each other and are necessary for design control compliance. Although, when designing a new product, the spe...

I believe that design validation would be the most important part of design controls. While one can be very precise in detailing the design and components of the device, the validation is where the pr...

As others have said beforehand, a poorly defined and disorganized development process will dive the design control into chaos. If a product were to be designed outside the boundaries of the tolerances...

I believe that placebo-controlled trials are ethical and necessary. As was mentioned in our lecture, around 20% of pain experienced is experienced in the mind. While pain can be a powerful feeling to ...

I believe that patients should be allowed to have informed consent when participating in clinical studies. While people's samples could be a huge factor in saving the lives of many, they, and their fa...

We had to do clinical trials in the Capstone Project I was involved. Our project focused on designing a toothbrush that would help with saliva collection. Our group already had IRB approval since we h...

Product Development is the basis or groundwork of marketing for the product. People gather together to develop an idea or a need for a product that customers would enjoy or desire. Primarily, they wou...

I guess a clever way of participation is having a virtual interaction with the company. I have encountered a live person willing to speak to me about a product that I was not pleased with. I believe i...

Like others have mentioned before, I also believe that product is the most essential to achieve in the marketing strategy. While the others are consequential, the process of making a well-intended and...