Download the fantastic book titled Development of FDA Regulated Medical Products written by Elaine Whitmore, available in its entirety in both PDF and EPUB formats for online reading. This page includes a concise summary, a preview of the book cover, and detailed information about "Development of FDA Regulated Medical Products", which was released on 15 February 2012. We suggest perusing the summary before initiating your download. This book is a top selection for enthusiasts of the Medical genre.
Summary of Development of FDA Regulated Medical Products by Elaine Whitmore PDF
Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. "I have been working in medical device design and design assurance for over 10 years...Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients!" Joseph P. Sener, P.E.
Detail About Development of FDA Regulated Medical Products PDF
- Author : Elaine Whitmore
- Publisher : Quality Press
- Genre : Medical
- Total Pages : 257 pages
- ISBN : 0873892216
- Release Date : 15 February 2012
- PDF File Size : 37,7 Mb
- Language : English
- Rating : 4/5 from 21 reviews
Clicking on the GET BOOK button will initiate the downloading process of Development of FDA Regulated Medical Products by Elaine Whitmore. This book is available in ePub and PDF format with a single click unlimited downloads.
