International Medical Device Clinical Investigations: A Practical Approach

Pieterse, Herman (Editor)/ Duijst, Peter (Editor)/ De Jong, M. G. (Editor)

ISBN 10: 0367399776 / ISBN 13: 9780367399771

Published by CRC Pr I Llc, 2019

About this Item

2nd new edition. 592 pages. 8.75x6.00x1.50 inches. In Stock.

Seller Inventory # x-0367399776

Bibliographic Details

• Title: International Medical Device Clinical Investigations: A Practical Approach
• Publisher: CRC Pr I Llc
• Publication Date: 2019
• Language: English
• ISBN 10: 0367399776
• ISBN 13: 9780367399771
• Binding: Paperback
• Edition: 2nd Edition
• Condition: Brand New
• Weight: 1.12 kilograms

About this title

Synopsis

The demand for clinical evidence has become an increasingly important issue in the development of medical devices. This demand is reflected not only in regulatory requirements but also by healthcare purchasers as healthcare reforms occur worldwide. Thirteen renowned experts have drawn on their practical experience in industry to provide you with this "recipe" book of how to plan, prepare, implement, and close out a medical device clinical investigation--regardless of where the trial site may be located. While many chapters reference the Medical Device Directive, the principles, philosophies, and methodologies explained are equally applicable to Active Implantable Medical Devices (AIMD) and In-vitro Diagnostic (IVD) products.

About the Author

Herman Pieterse, Marja G. de Jong , Peter Duijst