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Title: The CE Mark: Understanding the Medical Device Directive by Jan D. Coenraads, Brenda Van Broekhoven, Schaap Hartmann, Hugo Tander, Maud Veldkamp, Les Schnoll ISBN: 0-9650445-3-X Publisher: Paton Press Pub. Date: 01 August, 1997 Format: Paperback List Price(USD): $29.95 |
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Title: ISO 13485 (EN 46000) Requirements, 99 Requirements Checklist and Compliance Guide by Jack Kanholm, Lynette Howard ISBN: 1882711157 Publisher: AQA Press Pub. Date: 01 July, 1998 List Price(USD): $59.00 |
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Title: The Fda and Worldwide Quality System Requirements Guidebook for Medical Devices by Kimberly A. Trautman ISBN: 0873893778 Publisher: American Society for Quality Pub. Date: October, 1996 List Price(USD): $55.00 |
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Title: Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration by Gordon Harnack ISBN: 0873894553 Publisher: American Society for Quality Pub. Date: March, 1999 List Price(USD): $49.00 |
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Title: Quality Systems and GMP Regulations for Device Manufacturers: A Practical Guide to US, European, and ISO Requirements by Steven S. Kuwahara ISBN: 087389426X Publisher: Interpharm Press Pub. Date: 31 March, 1998 List Price(USD): $56.00 |
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