ABSTRACT

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effectiv

chapter 1|4 pages

Introduction

chapter 2|4 pages

Device classification

chapter 3|8 pages

Overview of design controls

chapter 4|12 pages

Design and development planning

chapter 5|8 pages

Design inputs—Part I

chapter 6|28 pages

Design inputs—Part II

chapter 7|4 pages

Design outputs

chapter 8|14 pages

Design review

chapter 9|4 pages

Design verification

chapter 10|12 pages

Risk management

chapter 11|6 pages

Design validation

chapter 12|18 pages

Biocompatibility

chapter 13|4 pages

Design transfer

chapter 14|4 pages

Design change

chapter 15|4 pages

Design history file

chapter 16|4 pages

The FDA inspection technique