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
Summary
"Based on the author's extensive experience in the medical devices and manufacturing engineering industries, this book can save medical device companies millions of dollars by preventing many deaths and costly recalls. It is the first to show how to control safety risks, starting from specifications to safely retiring the products without harm to the environment. The book covers medical device requirements, preventing recalls during specification writing, risk assessment and management, preventing recalls during design and development, and much more"--Provided by publisher
