Get the information you need to understand the ISO 13485:2003 and ISO 9001 standards and how they impact your organization. Dynamic group discussions focus on when compliance or registration is required or desirable, how to document and design an effective quality management system, what the revised requirements mean for the worldwide medical device industry, and what auditors are looking for and finding. Also covered are the steps and potential benefits of registration, such as increased productivity, cost effectiveness, higher perceived quality, enhanced internal and external communication, and competitive advantage. For a complete week of FDA regulatory training, combine this two-day interactive program with our Understanding FDA's Medical Device Quality System Regulation (2 days), FDA Quality System Inspectional Techniques (QSIT) (1 day), .