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Buy the book if you desire to master the ISO Standard. It is the most detailed, specific and accurate document you will find about the ISO Standard requirements giving you a direct presentation of techniques of how to develop and implement processes.

Maintain regulatory compliance by being ISO 13485 certified

It will motivate and inspire you. You will learn how to leverage your QMS in an effective and very easy to understand way.

And it will make your life easier when implementing the ISO Standard in your quality management system. Share on Tumblr.

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    ISO 13485:2016

    You already recently rated this item. Your rating has been recorded. Write a review Rate this item: 1 2 3 4 5. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context.

    The author has two active websites related to these topics, namely, www. Itay Abuhav. Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO standard requirements.