This book provides information and recommendations to help regulatory affairs and quality managers and consultants of software medical device design and development organizations navigate the complex course of regulatory compliance, operational excellence, product quality, and customer satisfaction to create an effective and efficient quality system. Software organization executives, functional managers, and other interested coworkers can also utilize this book to secure a general understanding of the subject matter.
Many consulting firms, industry associations, and educational institutions present regulatory and quality training opportunities to regulatory and quality students and professionals. However, most training events focus on specific topics or requirements, such as ISO 9000, FDA Quality System Regulations, Six Sigma, vendor qualification, and software design control. Regulations and standards typically provide concise statements of requirements, but not much more. This book fills that gap in information available to regulatory and quality professionals in the software medical device industry. The resultant operational management system outlined in Appendix A, the Software Medical Device Quality System Guidelines, provides these professionals with recommendations and considerations for implementing the potentially duplicative requirements in a manner that reduces the bureaucracy of the system and adds value toward satisfying the organization's objectives.
Included on a CD-ROM accompanying the book is Appendix A, Software Medical Device Quality System Guidelines.
Review By: Alan Madick 03/02/2007Depending upon your role within a system development project, you will likely have a different idea of what's critical to the success of that project. As a marketing person, you hope that the system is delivered with a fully functional feature set, so that you can sell to customers and prospects alike. As a financial person, you are most likely concerned with the project budget. However, as a caregiver or patient, your focus is most likely on product quality, as you place your trust in the product and hope that it functions as it's designed.
Safe and Sound Software focuses on product quality, an aspect of system development that is often overlooked but is critical to the software medical device market. The book is well organized and presented so as to drive home the importance of quality in a medical system.
It begins with an overview of why quality is important and discusses the ramifications of releasing a system that does not bring with it an acceptable level of quality. It emphasizes the costs—not only monetary but potentially in terms of loss of life. This is a critical point, as it provides the reader with ample justification to invest the time and resources needed to mitigate these risks. An exclamation point is added by providing case histories where software medical devices were released without ensuring the quality, along with the disastrous outcomes.
The style of this book is consistent and easy to read. Within each chapter, the author provides relevant definitions, along with both recommendations and mandatory processes to follow as software is designed, coded, tested, and implemented. It provides ample discussion on risk management, which is critical to a business where risk and mitigation play such a prominent role. It also provides the reader with an overview of some of the more influential regulatory and compliance guidelines, such as FDA, the Sarbanes-Oxley Act, and a myriad of international standards that must be considered when marketing these products to the world.
Finally, the book provides a nice recap of the quality system guidelines. This recap is provided in point form, and can provide the project team members with a checklist to follow as they travel down the road of software quality.
As an employee of a company that manufactures software medical devices, I found this book to be an invaluable guide and one that will likely be referenced time and time again. It clearly shows the importance of following an approved methodology, in terms of both patient safety and compliance to regulation. It is a realistic approach, and even includes a section on risk management, acknowledging the fact that even the best plans will bring some risk that can be mitigated by a well-thought-out risk management plan. Software testing is still the black sheep of the system development family, but this book elevates the software testing discipline to a place and status that it rightly deserves.
In the high-risk world of software medical device manufacturing, one cannot afford to take short cuts and compromise product quality. This book provides an outstanding guide to, and shows the importance of, implementing a quality software development methodology. It is essential reading for anyone who is responsible for designing, coding, testing, or implementing a software medical device.