The FDA's goal is to ensure medical devices are completely safe for the public, but in reality a 100% safe device is probably not going to exist past ...

When it comes to the FDA, I think strict is a positive. It is of utmost importance that the FDA is strict, unbiased, and efficient to keep American pe...

Though the 510K process requirement of connecting current devices to those manufactured in 1976 may seem nonsensical, it is important to note that dir...

It is difficult to say whether research for the future or the present is more important, both are necessary for the advancement of medical knowledge i...

I'm actually quite surprised that no responses have brought up bioreactors yet. Yes, it is true that the Institutional Animal Care and Use Committee (...

Extensive in vitro and in vivo testing is required to solidify the biocompatibility of a medical device throughout its entire lifecycle. Depending on ...

I really like this question as I am an athlete myself. I have learned the value of teamwork and the makeup of a good team throughout my years as a bas...

Avoiding scope creep can be quite the challenge in the engineering industry when you are dealing with such active thinkers and creative minds. However...

It is important to begin considering quality and risk management for a project as early as the planning phase to ensure the project remains on course....

Regulatory Affairs is an extremely important industry when it comes to developing new medical devices. FDA approval is necessary to ensure that produc...

Dr. Simon touched on this comparison in this week’s lectures. Academia can have positives if you are looking to do a lot of research and traveling wit...

As AI technology advances, it is almost a given that there will be changes affecting the medical industry. AI completely controlling the medical indus...