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

Price: ₹9,000.00
(as of Sep 23, 2023 15:23:09 UTC – Details)

This 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. ESSENTIALS OF MEDICAL DEVICE CLINICAL RESEARCH (VOLUME I) CONTENT 1) History of Medical Devices 2) Structure and Function of the International Medical Devices Regulators Forum (IMDRF) 3) Medical Devices Definition and Classification 4) Lifecycle of a Medical Device: From Concept to Proof of Concept and Further 5) Fundamental Differences between Drug and Medical Devices 6) Marketing Authorization Requirements for a Medical Device in the World 7) Basics of ISO 13485 8) Basics of ISO 14155 9) Addressing the diversity of Medical Device Types, its uses 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) CONTENT 13) Clinical Evidence, Substantial Equivalence or Design and Process Equivalence 14) Clinical Evidence by Clinical Experience for Medical Devices

Publisher ‏ : ‎ B. Jain Regular (1 January 2022); B Jain Publishers Pvt Ltd, Noida UP
Language ‏ : ‎ English
Hardcover ‏ : ‎ 875 pages
ISBN-10 ‏ : ‎ 8131927830
ISBN-13 ‏ : ‎ 978-8131927830
Item Weight ‏ : ‎ 2 kg 250 g
Dimensions ‏ : ‎ 25 x 19 x 7.5 cm
Country of Origin ‏ : ‎ India
Net Quantity ‏ : ‎ 1.00 Pack
Importer ‏ : ‎ Made in India
Packer ‏ : ‎ B Jain Publishers Pvt Ltd, Noida UP
Generic Name ‏ : ‎ Essentials of Medical Device Clinical Research (Vol 1 & 2)