Medical Device Guidelines and Regulations Handbook

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.

Guidelines.- ISO 10993 - Biological Evaluation of Medical Devices.- ISO 22442 - Medical Devices utilizing Animal Tissues and Their Derivatives.- ISO 14971 & 24971 - Medical Device Risk Management.- ISO 21534 - Non-Active Surgical Implants - Joint replacement implants.- ISO 16061 Instrumentation for Use in Association with Non-Active Surgical Implants.- ISO 13485 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.- ISO 19227- Implants for Surgery - Cleanliness of Orthopedic implants.- ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects.- ISO 11607 - Packaging for Terminally Sterilized Medical Devices.- ISO 11137 -1, 2 and 3 - Sterilization of Health Care Products.- ISO 11135 - Sterilization of Health Care Products -Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.- ISO 17665-1 - Sterilization of Health Care Products - Moist Heat.- Regulations.- FDA- CFR Title 21 - Food and Drugs: Parts 800 to 1299.- Global Medical Device Regulations (covering various individual countries).- EU 722/2012 - Animal Tissue Regulations in Effect for Some Medical Devices.- EU 2017/746 - In Vitro Diagnostic Medical Devices.- EU 1097/2006 - REACH.