Full Description
This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.
Contents
Chapter 1. INTRODUCTION.- Chapter 2. GENERAL MEDICAL USE.- Chapter 3. ANAESTHESIOLOGY.- Chapter 4. SIGNIFICANT AND NONSIGNIFICANT RISK CARDIOVASCULAR DEVICES.- Chapter 5. Significant Risk Dental Devices.- Chapter 6. Significant Risk Medical Devices- ENT (Ear, Nose & Throat).- Chapter 7. Advantages and Disadvantages of Gastroenterology and Urology Implants .- Chapter 8. Significant and non-significant risks of General and Plastic Surgery devices.- Chapter 9. General Hospital Devices.- Chapter 10. SIGNIFICANT RISK MEDICAL DEVICES NEUROLOGY.- Chapter 11. OBSTETRICS AND GYNECOLOGY INSTRUMENTS.- Chapter 12. Medical Devices-Ophthalmic Devices.- Chapter 13. ORTHOPEDICS.- Chapter 14. RADIOLOGY.- Chapter 15. Non Significant Risk Medical Devices.
