E1262 de 2005

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 Part II, 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.