ABSTRACT
The design and development of medical devices is an important area in the healthcare industry. Writing this book was challenging and time consuming, but it was also rewarding for us since we were able to learn and share a lot in the process. But it is our sincere hope that we were able to achieve what we set out to do. While leaders and professionals within the medical device industry ultimately make things happen, our effort in this book is to enable them with the clear understanding of how FDA’s Design Control and DFSS fit together.
