Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. More

"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compli

This book guides readers through the process of bringing a new medical device from proof-of-concept to the market.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. Thi

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In