Clinical Evaluation of Medical Devices: Principles and Case

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Clinical Evaluation of Medical Devices: Principles and Case Studies
- Used Book in Good Condition
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.
Country USA
Brand Humana
Manufacturer Humana
Binding Hardcover
UnitCount 1
Format Illustrated
EANs 9781588294227
ReleaseDate 0000-00-00

Country	USA
Brand	Humana
Manufacturer	Humana
Binding	Hardcover
UnitCount	1
Format	Illustrated
EANs	9781588294227
ReleaseDate	0000-00-00

Clinical Evaluation of Medical Devices: Principles and Case Studies

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