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International Medical Device Clinical Investigations : A Practical Approach, Second Edition - Herman Pieterse

International Medical Device Clinical Investigations

A Practical Approach, Second Edition

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

Hardcover Published: 30th April 1999
ISBN: 9781574910858
Number Of Pages: 592

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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.

Clinical Regulatory Environment
Design in Clinical Trials
Managing Multi-Dimensional Clinical Projects
Device Classification and Risk Assessment
Clinical Strategy Development
Clinical Trial Project Plan
Quality Assurance for Good Clinical Practices
Protocol Development
The Clinical Investigator's Brochure
The Investigator Contract
Informed Consent
The Design of Case Report Forms
Labeling and Instructions for Use
Ethics Committee Approval
Insurance and Clinic
Table of Contents provided by Publisher. All Rights Reserved.

ISBN: 9781574910858
ISBN-10: 157491085X
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 592
Published: 30th April 1999
Publisher: CRC PR INC
Country of Publication: US
Dimensions (cm): 24.13 x 17.15  x 3.81
Weight (kg): 0.93
Edition Number: 2
Edition Type: New edition