Titlebook: Clinical Evaluation of Medical Devices; Principles and Case Karen M. Becker,John J. Whyte Book 2006Latest edition Humana Press 2006 Monito

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https://doi.org/10.1007/978-3-031-08530-7t of useful devices for human use”. and “to protect the public health by requiring safeguards for human subjects of investigations, sound ethical standards, and procedures to assure development of reliable scientific data.”

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Gongtian Shen,Zhanwen Wu,Junjiao Zhangost importantly, this 2- to 5-years anticipated timeframe for coverage can be reduced if a reimbursement plan is implemented early in product development. When developing a reimbursement plan, companies should address the following questions, preferably while their product is still in the development phase:

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Regulatory Requirements for Clinical Studies of Medical Devices and Diagnosticst of useful devices for human use”. and “to protect the public health by requiring safeguards for human subjects of investigations, sound ethical standards, and procedures to assure development of reliable scientific data.”

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vided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development

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