ISO 13485

By Itay Abuhav

Subjects: Guides, manuels, Appareils et instruments, Equipment and Supplies, BUSINESS & ECONOMICS, Quality control, standards, General, BUSINESS & ECONOMICS / Industries / General, Quality Control, Quality control, Contrôle, Standards, Normes, Medical instruments and apparatus, Qualité, Industries, Instruments & Supplies, Equipment Design, Médecine, Manufacturing processes, Industrie, Handbooks, manuals, Manufactured Materials, MEDICAL, Medical instruments and apparatus industry

Description: "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.