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About this product
- DescriptionThe 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 in- tion in health care techlogies 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 w 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 techlogy 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 vel study designs.
- PublisherHumana Press Inc.
- Date of Publication15/12/2005
- SubjectMedical Nursing & Ancillary Services
- Place of PublicationTotowa, NJ
- Country of PublicationUnited States
- ImprintHumana Press Inc.
- Content Note53 black & white illustrations, biography
- Weight730 g
- Width155 mm
- Height235 mm
- Spine20 mm
- Edited byJohn J. Whyte,Karen M. Becker
- Format DetailsLaminated cover
- Edition Statement2nd ed. 2006
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