Significant and Nonsignificant Risk Medical Devices
Language: English
Published by Springer, Springer Aug 2025, 2025
- Softcover
- New
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germanybuchversandmimpf2000
AbeBooks seller since January 23, 2017
Condition: New
£ 73.94
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Add to basketItem description from seller
This item is printed on demand - Print on Demand Titel. Neuware -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.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 444 pp. Englisch.…
Seller Inventory # 9783031528408
- Title
- Significant and Nonsignificant Risk Medical Devices
- Author
- Prakash Srinivasan Timiri Shanmugam
- Publisher
- Springer, Springer Aug 2025
- Publication year
- 2025
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 10
- 3031528409
- ISBN 13
- 9783031528408
- Item weight
- 668 grams
- Dimensions
- 235x155x24 mm
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.
"Synopsis" may belong to another edition of this title.
About the Author
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 Toxicological Aspects of Medical Device Implants (Elsevier, 2020) and Leprosy: From Diagnosis to Treatment (Nova Science Publishers, 2020). He is the youngest to be elected as Fellow of Royal college of Physician, FRCP (London). He is also the Fellow of international medical sciences academy, (FIMSA).
Dr Indumathy Jagadeeswaran, PhD, is currently working as a Senior Research Associate with the Department of Pediatrics at UT Southwestern Medical Center, Dallas, Texas. She has been working in the field of physiology for over a decade. Dr. Jagadeeswaran has an M.S. in Biotechnology with Biochemistry (interdisciplinary) and a Ph.D. in Medical Physiology from the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Pondicherry, India. She has editorial experience as an associate editor for a peer-reviewed international journal and is presently a peer-review member of the Scientific Committee and Society. She has published several research articles in peer-reviewed international journals and is a co-author of the book Biocompatibility Protocols for Medical Devices and Materials (Elsevier, 2022)
"About the title" may belong to another edition of this title.
buchversandmimpf2000
Emtmannsberg, BAYE, Germany
AbeBooks seller since January 23, 2017
Shipping rates from Germany to U.S.A.
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