Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices

 

207,59 €
IVA incluido
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Editorial:
Springer Nature B.V.
Año de edición:
2010
ISBN:
9781617375583
207,59 €
IVA incluido
Disponible

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Sobre IBD

Part I. Fundamentals of Clinical Study Design and Evaluation Clinical Trials in Development and Marketing of Medical Devices Karen M. Becker Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics Daniel A. Kracov and Lisa M. Dwyer Requirements for Medicare Coverage and Reimbursement for Medical Devices Esther R. Scherb and Stuart S. Kurlander Postmarket Requirements for Significant Risk Devices Suzan Onel Applications of Bayesian Methods to Medical Device Trials Telba Z. Irony and Richard Simon Intellectual Property Protection for Medical Devices Fariborz Moazzam and Michael D. Bednarek HIPAA Compliance in Clinical Research Peter M. Kazon and Sharon D. Brooks Overview of Medicare Coverage of Clinical Trials Julie K. Taitsman Developing Drug-Device Combination Products With Unapproved Components Guy Chamberland Wall Street’s Perspective on Medical Device Evaluation: Innovation Investing Adam K. Galeon Part II. Case Studies Challenges in Conducting Implantable Device Trials: Left Ventricular Assist Device in Destination Therapy Ursula Maria Schmidt-Ott, Alan J. Moskowitz, Annetine C. Gelijns, Julie C. Choe, Michael Parides, and Deborah V. Davis Ascheim BELIEF: A Randomized, Sham-Procedure- Controlled Trial of Percutaneous Myocardial Laser Therapy Jan Erik Nordrehaug and Janet M. Fauls Clinical Trials of an Anti-Adhesion Adjuvant Michael P. Diamond Use of Multiple Imputation Models in Medical Device Trials Donald B. Rubin and Samantha R. Cook Case Studies on the Local Coverage Process Mitchell I. Burken Reimbursement Analysis: From Concept to Coverage Robin Bostic Polyurethane Pacemaker Leads: The Contribution of Clinical Expertise to the Elucidation of Failure Modes andBiodegradation Mechanisms Ken Stokes Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves Frederick J. Schoen The Use of Surrogate Outcome Measures: A Case Study: Home Prothrombin Monitors John J. Whyte Index

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