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Significant and Nonsignificant Risk Medical Devices, 1st ed. 2024

Langue : Anglais

Coordonnateurs : Timiri Shanmugam Prakash Srinivasan, Thangaraju Pugazhenthan, Sampath Thamizharasan, Jagadeeswaran Indumathy

Couverture de l’ouvrage Significant and Nonsignificant Risk Medical Devices
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.

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.

Prakash Srinivasan Timiri Shanmugam, Ph.D., ERT, is currently a senior toxicologist at Avanos Medical, Inc. Before Avanos Medical, he was a subject matter expert in biocompatibility at Baxter International, Inc. and Johnson & Johnson. Dr. Timiri Shanmugam has an MS and a Ph.D. in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras and completed his postdoctoral research at Tulane University and LSU Health Shreveport, Louisiana. He is the editor of five books, including the Medical Device Guidelines and Regulations Handbook (Springer, 2022), and the author of several book chapters. He has published research articles in various peer-reviewed international journals and conference proceedings/abstracts.

Thangaraju Pugazhenthan, MBBS, MD, DNB, MNAMS, PG.Diploma in Diabetology, is an assistant professor in the Department of Pharmacology at All India Institute of Medical Sciences (AIIMS),Raipur. Additionally he hold the Master of Business Administration, MBA (Hospital management). He previously worked in Central Health Services at the Central Leprosy Teaching and Research Institute. He received an MBBS from Madurai Medical College and did his post-graduate training at the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. He is the member of world association of medical editors (WAME). He has published more than 140 internationally indexed publications, including in The Lancet and The BMJ. He is co-editor of the book Medical Device Guidelines and Regulations Handbook (Springer, 2022), author of the books Newer Pharmacological Concepts of Managing Erythema Nodosum Leprosum (Lambert, 2017) and A Pharmacological Guide to Non-Steroidal Anti-Inflammatory Medications (Nova Science Publishers, 2021), and a contributing chapter author for the books Ophthalmology and Otorhinolaryngology in Tox

An essential resource for researchers and professionals in the medical device field; Thoroughly covers the distinctions between Significant Risk (SR) and Non-Significant Risk (NSR) device studies; Presents simplified guidelines and regulatory points.