ISO 13485 : a complete guide to quality management in the medical device industry

• Tác giả: Itay Abuhav
• Ngôn ngữ: eng
• ISBN-10: 1439866112
• ISBN-13: 978-1439866115
• Ký hiệu phân loại: 610.284 Medicine and health
• Thông tin xuất bản: CRC Press, 2012
• Mô tả vật lý: xi, 361 p. : , ill. ; , 24 cm.
• Bộ sưu tập: Khoa học ứng dụng
• ID: 122480
• Chủ đề: 1. Medical instruments and apparatus--Standards; 2. Medical instruments and apparatus industry--Quality control; 3. Equipment and Supplies--standards; 4. Equipment Design--standards; 5. Manufactured Materials--standards; 6. Quality Control

Tóm tắt

"The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures"--Provided by publisher.