Essentials of Medical Device Clinical Research (Vol 1, 2 & 3)

This book is a unique compilation of all that is needed fora clinical research professional in Medical Devices. The drug and device differin clinical science from various aspects, which are not only operations butalso are pragmatic. Missing regulatory harmonization and wide-spread diversityof the devices is among the additional factors that add to the complexity ofthe still-developing device clinical requirements. Amid existence of this grossdependency on drug methodology for device clinical studies, there werecontinuing discussions in the industry about a need for describing adifferentiated and distinguished process. Hence, over years, requirements fordrugs have evolved as significantly larger and better detailed than for medicaldevices, while medical device clinical studies continued to depend uponconventional retrofitting from drugs-oriented systems and methods.While there have been a few efforts from some authors, a fewregulatory bodies, and some universal standards forums like CDISC and ISO, anend-to-end compilation of all that is needed in medical device clinicalresearch was grossly missing before this book. In this book, the overallclinical research requirements for medical devices are compiled fromend-to-end. It has three main aspects, distributed over four parts. The firstpart is the basic concepts of medical devices and a small part on what areconvergences and diversities between clinical research of drugs and devices.This part provides a high-level background of the regulatory process of marketapproval for medical devices, so that the research professional understands thepurpose of the clinical research that they need to conduct. The second andthird parts include scientific aspects of clinical research including medicalwriting, data management, safety, medical coding, biostatistics and clinicaloperations. The fourth and the last part includes some extended applications inthe rapidly changing medical device technology such as software as medicaldevice, software in medical device, diagnostic devices etc. ESSENTIALS OF MEDICAL DEVICE CLINICAL RESEARCH (VOLUME I) CONTENT 1) History of Medical Devices 2) Structure and Function of the International MedicalDevices Regulators Forum (IMDRF) 3) Medical Devices Definition and Classification 4) Lifecycle of a Medical Device: From Concept to Proof ofConcept and Further 5) Fundamental Differences between Drug and Medical Devices 6) Marketing Authorization Requirements for a Medical Devicein the World 7) Basics of ISO 13485 8) Basics of ISO 14155 9) Addressing the diversity of Medical Device Types, itsuses and Human Factors in Clinical Research 10) Preclinical Studies for Medical Devices 11) Medical Device Risk management and Risk Benefit Analysis 12) Materiovigilance Concepts and Process  ESSENTIALS OF MEDICAL DEVICE CLINICAL RESEARCH (VOLUME II) CONTENT13) Clinical Evidence, Substantial Equivalence or Design andProcess Equivalence 14) Clinical Evidence by Clinical Experience for MedicalDevices 15) Translational Research: Deriving Clinical Real-WorldSafety, Performance and Efficacy of Medical Devices Data from their PreclinicalStudies and Unorganized Clinical use Data Like Complaints 16) Clinical Evaluation and Clinical Evaluation Report 17) The Process of Literature Search and Appraisal 18) The Clinical Investigation Basic Concept and ItsComparison with Drug Clinical Trials 19) Designing a Clinical Study for Medical Devices 20) The Clinical Investigation Plan 21) Patient Safety and Consent Document 22) Medical Coding for Medical DevicesSearching Tags: Dr Ashish Indani New Book, Book by Dr Ashish Indani, Allopathy Books, Book for Allopathic Diagnosis & Treatment