One of the most important good clinical practices in the FDA documents I found was 21 CFR Part 50, which has to do with the protection of human subjects, namely informed consent. This is such an impor...

Intellectual property is a tricky subject because the term of ownership becomes less clear in the way multiple parties are involved, but in the case of clinical trials, it is very clear who owns inven...

Clinical trials are expensive as well as time-consuming, so reducing a device to a semester is a very tough task to do and is impossible. In the capstone class, students are working together to get pr...

The qualifications of salespeople I've encountered are very different, which is mainly based on the chemical industry, where most of the people I knew to be salespeople had a technical degree and thei...

In the transition from engineering to sales, in my experience, I've seen people complete engineering degrees and then use that engineering degree in a sales position in a company. Most people have gai...

As a sales rep for a company, following up on cold calls and inquiries by customers about the products of the customers becomes essential for the company to acquire a sale and make a profit. Creating ...

Financially, companies wouldn't go about developing medical devices if they didn't see profit in the near future, but there are ways companies develop these devices even though they aren't profitable....

Going into business becomes a difficult process for one individual. The way I would do it is to get business partners on a product, like a start-up, and my partners would also invest in a common inves...

In the company I worked for, they weren't a very big company and were rather small, so I was boxed into one particular field while working there. My position had to do with different parts of manufact...

The Form 483 reminds me of this one case study I learned about, which had to deal with Harvard and some medical tests they were doing. The case study was based on the fact that Harvard was conducting ...

Manufacturing safety becomes a second thought often during manufacturing because many companies are concerned with profit and how much they can make. Having the safety-approved equipment becomes less ...

Quality assurance and quality control serve different purposes within the medical device field, where each complements the other. My background is in quality control, not in medical devices, but in la...

Switching from the engineering role to a regulatory role has always interested me because of the perks of the job that other jobs do not have. More and more regulatory roles are becoming remote due to...

Handling a pandemic is of course going to be messy, no matter which government agency handles it, and the way the FDA handled the vaccine rollout was probably the best that could've happened. The vacc...

The main impact on the project is product development as opposed to post-market management because of the nature of the project. In any project, most of the work is done during product development, bu...