Design Control for the Medical Device Industry, 2nd ed. [Book review

Abstract

This book begins with a general discussion of design controls and why they are necessary for medical device product development and manufacture. It then discusses how design controls relate to FDA inspections and deficiencies. It discusses device classification by giving examples of devices and their classification according to the FDA and European regulations. It does not contain details on how the classes were developed nor how to determine what class your particular product may belong. After giving an overview of design controls and design and development planning, the remainder of the text is based on a typical development process. Discussions include design inputs, design outputs, design review, design verification, risk management, design validation, biocompatibility, design transfer, and design change. There is no discussion on the manufacturing process and how it may be affected by design controls. The main portion of the text concludes with discussions on the design history file and the FDA inspection. The chapter on the FDA inspection is basically the process flow for inspecting the design control requirements. It offers no advice on how to handle problems if they occur or what consequences may happen if the inspection is not passed. The text concludes with 11 appendices containing QARA (Quality Assurance and Regulatory Affairs consulting services and training company) documents. The text is a general introduction to the design control process. It would be a good text for someone not familiar with design controls and wanting a very basic understanding. It would require more research to become fully aware of the necessary information to produce a safe, effective, and reliable product. In addition, the book seems to prioritize making the design control process a necessity for making a company financially successful, rather than emphasizing its necessity to successfully produce a safe, effective, and reliable product.