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Medical Device Guidelines and Regulations Handbook

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  • © 2022

Overview

  • A critical resource for researchers and professionals in the medical device field
  • Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR
  • Presents simplified guidelines and regulation points

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About this book

This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing.  

  • A critical resource for researchers and professionals in the medical device field;
  • Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR;
  • Presents simplified guidelines and regulation points.

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Keywords

Table of contents (18 chapters)

Editors and Affiliations

  • Global Product Safety & Toxicology Avanos Medical, Inc., Alpharetta, USA

    Prakash Srinivasan Timiri Shanmugam

  • Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Raipur, India

    Pugazhenthan Thangaraju

  • R&D Engineer, Medical Devices, Milpitas, USA

    Nandakumar Palani

  • Department of Pharmacology, Maitri College of Dentistry & Research Centre, Anjora, Durg, India

    Thamizharasan Sampath

About the editors

Prakash Srinivasan Timiri Shanmugam, Ph.D., ERT, is currently working as 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 the books Understanding Cancer Therapies (CRC Press), Trends in Development of Medical Devices and Toxicological Aspects of Medical Device Implants (both Academic Press), and the author of several book chapters. He has published research articles in several peer-reviewed international journals and conference proceedings/abstracts.

Thangaraju Pugazhenthan, MBBS, MD, DNB, MNAMS, PGD (Diabetology), is an assistant professor in the Department of Pharmacology at All India Institute of Medical Sciences (AIIMS), Raipur. 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 has published more than 110 internationally indexed publications, including in The Lancet and The BMJ. He is the 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).

Nandakumar Palani, M.Sc.,is a research and development (R&D) engineer and a subject matter expert with more than 14 years of experience in medical device software engineering and manufacturing. He has a master’s degree in electronics from the University of Madras and an advanced diploma in embedded systems. He is the author of several book chapters on software engineering and medical regulations and standards for medical device design and manufacturing.

Thamizharasan Sampath Ph.D., PGDCR, is currently working as a professor in the Department of Pharmacology and as Scientist in Charge, Central Research Lab, at ACS Medical College and Hospital. He received his Master’s and Ph.D. degrees in pharmacology from the Post Graduate Institute of Basic Medical Sciences and a post-graduate diploma in clinical research from Annamalai University. Dr. Thamizharasan is the author of Bamboo - The Golden Rice (Lambert, 2018), a book on the use of bamboo in medicine, as well as several book chapters. He has published research articles in peer-reviewed international journals and is a reviewer for medical journals. He is a member of the Institutional Research Ethics Committee, Animal Ethics Committee, and Indian Pharmacological Society.


Bibliographic Information

  • Book Title: Medical Device Guidelines and Regulations Handbook

  • Editors: Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath

  • DOI: https://doi.org/10.1007/978-3-030-91855-2

  • Publisher: Springer Cham

  • eBook Packages: Engineering, Engineering (R0)

  • Copyright Information: The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022

  • Hardcover ISBN: 978-3-030-91854-5Published: 23 April 2022

  • Softcover ISBN: 978-3-030-91857-6Published: 23 April 2023

  • eBook ISBN: 978-3-030-91855-2Published: 22 April 2022

  • Edition Number: 1

  • Number of Pages: VI, 385

  • Number of Illustrations: 2 b/w illustrations, 12 illustrations in colour

  • Topics: Biomedical Engineering and Bioengineering

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