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Clinical Evaluation of Medical Devices - Principles and Case Studies (Hardcover, 2nd ed. 2006)
Loot Price: R5,624
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Clinical Evaluation of Medical Devices - Principles and Case Studies (Hardcover, 2nd ed. 2006)
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The original edition of this text, Clinical Evaluation of Medical
Devices: Principles and Case Studies, provided the first overview
of key pr- ciples and approaches to medical device clinical trials,
illustrated with a series of detailed, real-world case studies. The
book is designed as a resource for clinical professionals and
regulatory specialists working in the field of new medical device
development and marketing. Since the first edition of this text was
published in 1997, the rapid pace of inno- tion in health care
technologies continues to yield exciting and important new
products. The regulatory landscape has also evolved, reflecting
some of the changes and needs within the medical device industry.
The purpose of Clinical Evaluation of Medical Devices: Principles
and Case Studies, Second Edition is to provide an updated and
expanded presentation of the scientific methods and regulatory
requirements applied to the study of new significant risk medical
devices. The text now includes (1) new information on the
requirements and process for gaining reimbursement of new products
from Medicare and private insurers, with case studies of research
specifically designed for this p- pose as well as health care
technology assessment methods; (2) infor- tion on new statistical
methodologies applied to medical device trials; and (3) all new
case studies, including examples of combination pr- ucts,
three-phase development models (i. e. , feasibility, FDA approval,
Medicare reimbursement), and novel study designs.
General
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