Overview

Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards have been established, and the book also discusses medical devices within this regulatory framework. The book covers a broad range of disease topics and disease-specific implants and an interdisciplinary team of experts brings a wealth of information on implants used in various disease models and associated risk factors. Toxicological Aspects of Medical Device Implants is a comprehensive resource for toxicologists, biomedical engineers, immunologists, medical staff, regulators, and manufacturers working in the field who need to be aware of the potential toxicity and device management of such a wide variety of implants and devices and their health risks.

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9780128207284

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Prakash Srinivasan Timiri Shanmugam, PhD, is currently a Senior Toxicologist at Avanos Medical, Inc. in Alpharetta, Georgia. He was previously contracted as an SME–Biocompatibility at Baxter International, Inc. in Round Lake, IL, United States, and at Johnson & Johnson Medical Device Sector. He has an MSc and a PhD in the specialization of Pharmacology and Toxicology with Chemistry (interdisciplinary) from the University of Madras, Tamil Nadu, and completed his postdoctoral research at Tulane University and LSUHSC-Shreveport, Louisiana. He has authored 5 books, contributed several book chapters, and published research articles in various peer-reviewed international journals and conference proceedings/abstracts. Logesh Chokkalingam completed his Bachelors Degree in Mechanical Engineering from Vellore Institute of Technology. Also he has completed his Diploma in Tool and Die Making from NTTF, Specialized course in Design and Manufacturing of Press Tools, Injection Moulds and Jigs & Fixtures. Mechanical Engineer with specialized knowledge on design & development, Program management in various Medical devices regulations, supply chain integration, portfolio optimization, asset transfer, Verification testing and Validation, and Value Engineering. Innovative, detailed – oriented problem solver with strong program management skills. Experience working in a collaborative environment. Implement and suggest new process to improve existing manufacturing process. Flexible to work in domestic and international settings. Responsible for Global partnering of MDR Programs, Spine account management globally, developing CoE for Biocompatibility and Product Stewardship Pramila Bakthavachalam, PhD., FASC (AW), MRQA is a Technical Manager, Toxicology and Biocompatibility at HCL Technologies PVT Ltd. In Chennao, India. She is also on contract with Johnson & Johnson as Senior Toxicologist for Biocompatibility of Medical Devices. She has a Doctorate in Environmental Toxicology/ Biotechnology and M.Phil in Microbiology and has around 14 years of experience in regulatory toxicology as a Scientist and in Quality Assurance. She was instrumental in establishing a preclinical testing facility at Sri Ramachandra University and acquiring GLP certification for the same. She has 17 publications both national and international journals in various disciplines such as Environmental Toxicology, Toxicology and Pharmacology.

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