By Marie B. Teixeira, CRC Press, 2014, ISBN-13: 978-1-138-07371-5, xi+ 193 pages, $210
I have spent more than 30 years in the medical device industry. During this time, I have written ten texts on medical device design, medical device standards and regulations, and medical device reliability. I have also served on technical committees working on developing medical device standards, including ISO 13485 and worked with the FDA on developing medical software regulations, including IEC 62304. During this time, I have reviewed many texts on Quality Systems and regulations. I was interested to review this text to see how it dealt with current regulations.
According to the preface, in a book such as this, which covers the design control requirements applicable to a broad range of products and companies, it is often difficult and likely impossible to include every opinion or interpretation of the requirements or present the information in a manner that addresses everyone’s specific situation. This was evident throughout the book. The book has expanded its scope to include ISO 9001 and ISO 13485 requirements.
The text begins with a general discussion of design controls and why they are necessary. 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 documents contain examples of forms that could be used for a development process. I was disappointed by the documents that were linked to a specific training company rather than including references to regulations and standards, but the author is a principal consultant for QARA. The reference section does include FDA and international regulatory group 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.
—Review by Richard C. Fries