Corporations are mainly based on money and profit. In the lecture, we discussed the difference between S-Corp and C-Corp. It is mentioned that in a C-Corp there is double taxation which I find to be a...

It was mentioned in the lecture that typically medical device companies only release a medical device into the market if it has a margin 70-80%. I think that this is highly unethical. If a product is ...

Sole proprietorship is a type of business owned and run by ONE person. There is no distinction between the owner and the company. The owner is entitled to all the profit the company makes and is respo...

One of the roles in the quality management system is regulatory affairs specialist. The specialist help in obtaining and maintaining government approval for any medical device or drugs or any related ...

In lecture, the quality unit was mentioned. It can vary from one company to another. It can range from regulatory affairs, quality assurance, quality control, to document control, training, and compla...

I think it is very important to keep up with emerging technologies especially when it comes to the QA department as it facilitates their processes and makes it easier and more efficient. One of the wa...

Pergolide is an ergo line-based dopamine receptor agonist used to treat Parkinson’s disease. It was approved for use in 1988. In around 2002, detrimental side effects started emerging in patients that...

I think that the FDA is being strict with their restrictions which is absolutely necessary to ensure that all innovations do not harm the population. The medical industry is mainly based on profit, so...

I believe that the FDA should be responsible for the said issue. The FDA’s mission statement is to protect the public health by ensuring the safety and efficacy of drugs, medical devices, and food sup...

People who usually work in academia doing research do it out of curiosity and for their love of science. They genuinely want to help people by making new discoveries in science. Moreover, it is a more...

I think that testing on animals is unethical because it causes suffering to animals. Their rights are being violated. There are other alternatives to testing on animals: in vitro testing, computer (in...

If I had the choice right now, then I would choose to go into industry. I very much dislike working in slow paced environments where I have to search for the unknown. However, I would like to go into ...

Since thousands of lives are being affected by medical devices, a team dynamic in a medical device project should be open and transparent. It would be great if the project manager has some background ...

I have personally never worked on a project with multiple different project managers. Although it’s not very common, but I believe that having more than one project manger has its benefits especially ...

During the planning phase of the project, the manager has to set a specific budget for the project. The project manager can sometimes fail to account for risks and contingencies which results in the b...