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B01=Indumathy Jagadeeswaran
B01=Prakash Srinivasan Timiri Shanmugam
B01=Pugazhenthan Thangaraju
B01=Thamizharasan Sampath
Category1=Non-Fiction
Category=MBGR
Category=MQW
COP=Switzerland
Delivery_Pre-order
Language_English
PA=Not yet available
Price_€100 and above
PS=Forthcoming
softlaunch

Significant and Nonsignificant Risk Medical Devices

English

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.

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Current price €107.34
Original price €112.99
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Age Group_Uncategorizedautomatic-updateB01=Indumathy JagadeeswaranB01=Prakash Srinivasan Timiri ShanmugamB01=Pugazhenthan ThangarajuB01=Thamizharasan SampathCategory1=Non-FictionCategory=MBGRCategory=MQWCOP=SwitzerlandDelivery_Pre-orderLanguage_EnglishPA=Not yet availablePrice_€100 and abovePS=Forthcomingsoftlaunch

Will deliver when available. Publication date 07 Sep 2024

Product Details
  • Dimensions: 155 x 235mm
  • Publication Date: 07 Sep 2024
  • Publisher: Springer International Publishing AG
  • Publication City/Country: Switzerland
  • Language: English
  • ISBN13: 9783031528378

About

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).Thamizharasan Sampath PhD is currently Dean Research and Professor of Pharmacology & Toxicology at University of Health Sciences (SBIMS) Raipur CG India. He has done MS and PhD specializing in pharmacology under faculty of Medicine from Post Graduate Institute of Basic Medical Sciences University of Madras and also did his Post graduate diploma in Clinical Research from State University. He has 17 years of teaching and research experience. His Research area includes cancer pharmacology clinical research neurotoxicology nutraceuticals Reproductive toxicology endocrine pharmacology Phyto pharmacology molecular pharmacology drug design and drug discovery. He has published more than 70 research articles in national and international indexed Journals. He is co-editor of the books Medical Device Guidelines and Regulations Handbook(springer) Biocompatibility Protocols for Medical Devices and Materials(Elsevier) and author of the book Bamboo-The Golden seed and also contributed more than 20 book chapters. He has received many awards from various central organizations for his outstanding Research and contribution in the field of Medicine. He serves as chief Editor Editorial board member and Reviewer in many medical journals. Member in Institutional Research Ethics committee Animal ethics committee Indian Pharmacological Society and also member of UNESCO Bioethics committee. 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) 

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