1. Introduction to medical device requirements -- 2. Preventing recalls during specification writing -- 3. Risk assessment and risk management -- 4. Preventing recalls during early design -- 5. Preventing recalls during the detail design phase -- 6. Designing for prognostics to protect patients -- 7. Preventing recalls during production validation -- 8. Preventing software design recalls -- 9. Preventing supply chain quality defects to avoid recalls -- 10. Preventing recalls using a verification process -- 11. Preventing recalls using design validation process -- 12. Recall planning to maximize efficiency in the event of a recall -- 13. Role of management in preventing recalls -- 14. Innovation methods useful in preventing recalls -- 15. Proactive role of marketing in preventing recalls.