Safety Evaluation in the Development of Medical Devices and Combination Products

Safety Evaluation in the Development of Medical Devices and Combination Products
Author :
Publisher :
Total Pages : 576
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ISBN-10 : 1000763390
ISBN-13 : 9781000763393
Rating : 4/5 (90 Downloads)

Book Synopsis Safety Evaluation in the Development of Medical Devices and Combination Products by : Shayne C. Gad

Download or read book Safety Evaluation in the Development of Medical Devices and Combination Products written by Shayne C. Gad and published by . This book was released on 2001 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt:


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While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotox
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The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO anal