Clinical evaluation of medical devices
By: edited by Karen M. Becker, John J. Whyte.
Contributors: Becker, Karen M.; Whyte, John J. 1966-
Edition: 2nd ed.
Publisher: Humana Press
Published: 2006
Place of publication: Totowa, N.J
Language: eng
Subjects: Medical instruments and apparatus -- Evaluation; Clinical trials; Equipment and Supplies -- standards; Clinical Trials -- standards; Device Approval -- standards; Evaluation Studies
Notes: Includes bibliographical references and index.
Table of contents: title: Clinical trials in development and marketing of medical devices / Karen M. Becker; title: Regulatory requirements for clinical studies of medical devices and diagnostics / Daniel A. Kracov and Lisa M. Dwyer; title: Requirements for medicare coverage and reimbursement for medical devices / Esther R. Scherb and Stuart S. Kurlander; title: Postmarket requirements for significant risk devices / Suzan Onel; title: Application of bayesian methods to medical device; title: Trials / Richard Simon and Telba Z. Irony; title: Intellectual property protection for medical devices / Faffi Moazzam and Michael D. Bednarek; title: HIPAA compliance in clinical research / Peter M. Kazon and Sharon D. Brooks; title: Medicare coverage of clinical trials / Julie K. Taitsman; title: Developing drug/device combination products  with unapproved components / Guy Chamberland; title: Wall Street's perspective on medical device evaluation / Adam K. Galeon; title: Challenges in conducting implantable device trials: left ventricular assist device in destination therapy / Davis Ascheim, Michael Parides, and Alan J. Moskowitz; title: BELIEF: a randomized, sham-procedure-controlled trial of percutaneous myocardial laser therapy / Jan Eric Nordrehaug; title: Clinical trials of an anti-adhesion adjuvant / Michael P. Diamond; title: Use of multiple imputation models in medical device trials / Donald B. Rubin and Samantha R. Cook; title: Case studies on local coverage process / Michael I. Burken; title: Reimbursement analysis: from concept to coverage / Robin Bostic; title: Polyurethane pacemaker leads: the contribution of clinical experience to the elucidation of failure modes and biodegradation mechanism / Ken Strokes; title: Role of device retrieval and analysis in the evaluation of substitute heart valves / Frederick J. Shoen; title: Home prothromin monitoring: evidence-based medicine exemplified in the medicare coverage process / John J. Whyte.