Clinical evaluation of medical devices

Print version:

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