{"product_id":"essentials-of-medical-device-clinical-research","title":"Essentials of Medical Device Clinical Research (Vol  1, 2, 3 \u0026 4)","description":"\u003cp class=\"MsoNormal\"\u003eThis book is a unique compilation of all that is needed for a\u003cspan\u003e \u003c\/span\u003e\u003ca href=\"https:\/\/www.bjainbooks.com\/product-detail\/essentials-of-medical-device-clinical-research-vol-1-2\"\u003eclinical research professional in Medical Devices\u003c\/a\u003e. The drug and device differ in clinical science from various aspects, which are not only operations but also are pragmatic. Missing regulatory harmonization and wide-spread diversity of the devices is among the additional factors that add to the complexity of the still-developing device clinical requirements. Amid existence of this gross dependency on drug methodology for device clinical studies, there were continuing discussions in the industry about a need for describing a differentiated and distinguished process. Hence, over years, requirements for drugs have evolved as significantly larger and better detailed than for medical devices, while medical device clinical studies continued to depend upon conventional retrofitting from drugs-oriented systems and methods.\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003eWhile there have been a few efforts from some authors, a few regulatory bodies, and some universal standards forums like CDISC and ISO, an end-to-end compilation of all that is needed in medical device clinical research was grossly missing before this book. In this book, the overall clinical research requirements for medical devices are compiled from end-to-end. It has three main aspects, distributed over four parts. The first part is the basic concepts of medical devices and a small part on what are convergences and diversities between clinical research of drugs and devices. This part provides a high-level background of the regulatory process of market approval for medical devices, so that the research professional understands the purpose of the clinical research that they need to conduct. The second and third parts include scientific aspects of clinical research including medical writing, data management, safety, medical coding, biostatistics and clinical operations. The fourth and the last part includes some extended applications in the rapidly changing medical device technology such as software as medical device, software in medical device, diagnostic devices etc.\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003ca href=\"https:\/\/www.bjainbooks.com\/product-detail\/essentials-of-medical-device-clinical-research-vol-1-2\"\u003eESSENTIALS OF MEDICAL DEVICE CLINICAL RESEARCH\u003c\/a\u003e\u003cb\u003e\u003cspan\u003e \u003c\/span\u003e(VOLUME I) CONTENT\u003co\u003e\u003c\/o\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e1) History of Medical Devices\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e2) Structure and Function of the International Medical Devices Regulators Forum (IMDRF)\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e3) Medical Devices Definition and Classification\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e4) Lifecycle of a Medical Device: From Concept to Proof of Concept and Further\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e5) Fundamental Differences between Drug and Medical Devices\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e6) Marketing Authorization Requirements for a Medical Device in the World\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e7) Basics of ISO 13485\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e8) Basics of ISO 14155\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e9) Addressing the diversity of Medical Device Types, its uses and Human Factors in Clinical Research\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003co\u003e\u003c\/o\u003e10) Preclinical Studies for Medical Devices\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e11) Medical Device Risk management and Risk Benefit Analysis\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e12) Materiovigilance Concepts and Process\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e \u003ca href=\"https:\/\/www.bjainbooks.com\/product-detail\/essentials-of-medical-device-clinical-research-vol-1-2\"\u003eESSENTIALS OF MEDICAL DEVICE CLINICAL RESEARCH\u003c\/a\u003e\u003cb\u003e\u003cspan\u003e \u003c\/span\u003e(VOLUME II) CONTENT\u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e13) Clinical Evidence, Substantial Equivalence or Design and Process Equivalence\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e14) Clinical Evidence by Clinical Experience for Medical Devices\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e15) Translational Research: Deriving Clinical Real-World Safety, Performance and Efficacy of Medical Devices Data from their Preclinical Studies and Unorganized Clinical use Data Like Complaints\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003co\u003e\u003c\/o\u003e16) Clinical Evaluation and Clinical Evaluation Report\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003co\u003e\u003c\/o\u003e17) The Process of Literature Search and Appraisal\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e18) The Clinical Investigation Basic Concept and Its Comparison with Drug Clinical Trials\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e19) Designing a Clinical Study for Medical Devices\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e20) The Clinical Investigation Plan\u003co\u003e\u003c\/o\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e21) Patient Safety and Consent Document\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e22) Medical Coding for Medical Devices\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eVolume 3: \u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003eThis book is a unique compilation of all that is needed for a clinical research professional in Medical Devices. The drug and device differ in clinical science from various aspects, which are not only operations but also are pragmatic. Missing regulatory harmonization and wide-spread diversity of the devices is among the additional factors that add to the complexity of the still-developing device clinical requirements. Amid existence of this gross dependency on drug methodology for device clinical studies, there were continuing discussions in the industry about a need for describing a differentiated and distinguished process. Hence, over years, requirements for drugs have evolved as significantly larger and better detailed than for medical devices, while medical device clinical studies continued to depend upon conventional retrofitting from drugs-oriented systems and methods. While there have been a few efforts from some authors, a few regulatory bodies, and some universal standards forums like CDISC and ISO, an end-to-end compilation of all that is needed in medical device clinical research was grossly missing before this book.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003eVolume 4: \u003c\/b\u003e\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003eThis book is a unique compilation of all that is needed for a clinical research professional in Medical Devices. The drug and device differ in clinical science from various aspects, which are not only operations but also are pragmatic. Missing regulatory harmonization and wide-spread diversity of the devices is among the additional factors that add to the complexity of the still-developing device clinical requirements. Amid existence of this gross dependency on drug methodology for device clinical studies, there were continuing discussions in the industry about a need for describing a differentiated and distinguished process. Hence, over years, requirements for drugs have evolved as significantly larger and better detailed than for medical devices, while medical device clinical studies continued to depend upon conventional retrofitting from drugs-oriented systems and methods. While there have been a few efforts from some authors, a few regulatory bodies, and some universal standards forums like CDISC and ISO, an end-to-end compilation of all that is needed in medical device clinical research was grossly missing before this book.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e \u003c\/p\u003e","brand":"INDANI ASHISH","offers":[{"title":"Default Title","offer_id":41933633814614,"sku":"9788131927830","price":15300.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0615\/0760\/0470\/files\/9788131927830_3D_VOL_i_ii_iii_iv.jpg?v=1780740896","url":"https:\/\/www.bjainbooks.com\/products\/essentials-of-medical-device-clinical-research","provider":"BJAIN BOOKS LLP","version":"1.0","type":"link"}