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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.

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. 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.

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

15) 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

16) Clinical Evaluation and Clinical Evaluation Report

17) The Process of Literature Search and Appraisal

18) The Clinical Investigation Basic Concept and Its Comparison 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 Devices