As a MS student working in research right now, from my short experience, the IRB is in charge of reviewing all research protocols. Whatever test is being run in the lab, the IRB is the ruling factor i...

The FDA does give some guides to how the test should be run but the general rule of thumb is to have a test for every claim that your product proposes will happen to the human using the medical device...

Design controls were made so that companies have documentation for every step of their design process, and so that these documents can be reviewed to consistently find any design and technical errors....

Verification tells a company that the developed device meets the requirements for the product. This is done through tests and a lot of analysis, which are operations that cost companies money to perfo...

Design controls are required by the FDA pretty much to ensure the developed device is safe for public use. While the company has to spend resources to create design controls, it also structures the de...

Design inputs can greatly affect the functionality of a device. Therefore, one of the greatest factors in design inputs are the device's functions. The design inputs have to comply with the requiremen...

It is very important to have consent from the patient. Today, not only in medicine but also in other fields, consent to use a users information is a must. When you sign up for Facebook, you're consent...

PCTs are definitely ethical and necessary. The placebo effect is real so to ensure that it is not what is making the cause of a change in a person's health due to a medical device or drug, it needs to...

I think for the most part everyone is in agreement that the Right to Try act is good thing; it gives people who are close to losing hope a chance to try something risky but potentially life saving, an...

A great advertisement that I saw was on Instagram for this phone game where you move a sphere through a track and you can only touch the color of the sphere, not any other color. 2 things about this a...

Marketing is just getting people to know about your product and the good things about it. For people in the market looking to buy a medical product, there are obviously ads that they will see through ...

I don't consider sales as manipulation. Salesmen try to be friendly to customers so that customers don't dislike them. Why? Because if you were a customer, you wouldn't want to buy anything from someo...

My answer depends on what kind of company I would be starting, but I would generally lean towards an LLC like many other people would. If I wanted to quickly start making phone apps and selling them, ...

LLPs die when one owner dies, so beyond the limited liability part, there aren't so many benefits to an LLP. That's why, as per mentioned above, LLP's aren't used very much. Furthermore, it's less lik...

I remember reading once that businesses that are partnerships perform better than sole-proprietorships because the partners push each other to do well. I think that when it comes down to it, a partner...