Clinical evaluation of medical devices : principles and case studies : [electronic book] /
Contributor(s): Becker, Karen M [editor] | Whyte, John J [editor] | ProQuest [vendor]
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Publisher: Totowa, New Jersey : Humana Press, 2006Edition: 2nd edition.Description: 1 online resource (x, 346 pages) : illustrations.Content type: text Media type: computer Carrier type: online resourceISBN: 1597450049; 9781597450041:; 9781597450041.Subject(s): Medical instruments and apparatus -- Evaluation | Clinical trials | Equipment and Supplies -- standards | Clinical Trials -- standards | Device Approval -- standards | Evaluation StudiesOnline resources: Access ebook here Item type | Current library | Call number | Status | Date due | Barcode | Item holds |
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ATU Sligo Yeats Library eBook | Available Online |
Includes bibliographical references and index.
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 / Richard Simon and Telba Z. Irony -- Intellectual property protection for medical devices / Faffi 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 / Adam K. Galeon -- Challenges in conducting implantable device trials: left ventricular assist device in destination therapy / Davis Ascheim, Michael Parides, and Alan J. Moskowitz -- BELIEF: a randomized, sham-procedure-controlled trial of percutaneous myocardial laser therapy / Jan Eric Nordrehaug.
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 local coverage process / Michael I. Burken -- Reimbursement analysis: from concept to coverage / Robin Bostic -- Polyurethane pacemaker leads: the contribution of clinical experience to the elucidation of failure modes and biodegradation mechanism / Ken Strokes -- Role of device retrieval and analysis in the evaluation of substitute heart valves / Frederick J. Shoen -- Home prothromin monitoring: evidence-based medicine exemplified in the medicare coverage process / John J. Whyte.
Containing examples of actual device development and testing, this book serves as a technical resource for scientific and regulatory professionals working in the field of new medical device development and commercialisation.