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This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management…
Hardback – 2018-05-15
Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a…
Paperback – 2017-03-29
What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you maintain…
Hardback – 2017-02-07