- Software Development
- Medical Devices
- Product Development and Recall
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.