Clinical Evaluation of Medical Devices Principles and Case Studies /

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: Becker, Karen M. (Επιμελητής έκδοσης), Whyte, John J. (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Totowa, NJ : Humana Press, 2006.
• Έκδοση: Second Edition.
• Θέματα: Materials science.; Biomaterials.; Materials Science.

Highly praised in its first edition, Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition has been expanded and updated to include the many innovations and clinical research methods that have developed since the first edition, as well as current information on the regu...

Πίνακας περιεχομένων:

• Fundamentals of Clinical Study Design and Evaluation
• Clinical Trials in Development and Marketing of Medical Devices
• Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics
• Requirements for Medicare Coverage and Reimbursement for Medical Devices
• Postmarket Requirements for Significant Risk Devices
• Applications of Bayesian Methods to Medical Device Trials
• Intellectual Property Protection for Medical Devices
• HIPAA Compliance in Clinical Research
• Overview of Medicare Coverage of Clinical Trials
• Developing Drug-Device Combination Products With Unapproved Components
• Wall Street’s Perspective on Medical Device Evaluation
• Case Studies
• Challenges in Conducting Implantable Device Trials
• BELIEF
• Clinical Trials of an Anti-Adhesion Adjuvant
• Use of Multiple Imputation Models in Medical Device Trials
• Case Studies on the Local Coverage Process
• Reimbursement Analysis
• Polyurethane Pacemaker Leads
• Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves
• The Use of Surrogate Outcome Measures.