I agree with the last statement that clinical studies are necessary for discovery, although I am conflicted with risking human lives for such advancem...

I do believe that having a clinical background would be of benefit in certain roles, such as the Principle Investigator or the Study Coordinator. Most...

Rather than being considered separate entities, let us think of sales as a subcategory within product management. Product management is considered ove...

The function of product development is to plan how to develop a new product, actually manufacture it, and sell the product to consumers. There are a f...

Advertising is a critical component of marketing, and if not executed effectively, could be the make or break of a product. Within the Four P’s of Mar...

Prior to this lecture, I don't believe I really put any thought into this topic. To say I'm an engineer, it makes sense that I was unfamiliar with jus...

In short, there really is not a correct answer to this question. Although of course an influence, the type of corporation chosen will not determine if...

It is true that the initial cost of investment with a partnership will be split between the partners; however, I would not consider this a lower risk ...

As I am still new in industry, I have yet to meet someone who believes Quality is a burden; but from the perspective of a Supplier Quality Engineering...

A Form 483 is given by the FDA when a company fails to comply with the practices set in place by their own Quality Management System (QMS) or the FDA'...

I do agree there is a game being played between physicians and drug companies- you go to the doctor, tell them what's wrong, they prescribe you some p...

Accuracy is defined as how well a value agrees with the a standard measurement of comparison. In regard to medical devices, accuracy can mean a few th...

There are many challenges that go into the creation of a medical device, whether that it be novel or a predicate device. During the pre-market lifecyc...

During this MDD course is the first I was made aware of what the FDA's mission statement is. I actually giggled out loud at the second portion which c...

I would like to respond to this question by respectfully challenging the initial hypothesis of academic research creating results for future generatio...