Transition of ISO 13485: 2003 to ISO 13485:2016. The changes and its application: A Case Study: The Practical Guide
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ISO 13485 certification is required by the organization who are dealing with medical devices in any of the stage of its product life cycle. It is either required by its customer or the regulatory authorities. ISO 13485 released the 3rd revision on March 2016 from ISO 13485:2003 to ISO 13485:2016 and allows three years of transition period. ISO 13485:2003 will be withdrawn on February 28th, 2019.This book listed the requirements in ISO 13485:2003 and ISO 13485:2016. Both revision of the standards is compared with the difference in the requirements. The requirements of ISO 13485 are briefly given in this book. The changes of the requirements are discussed extensively.
Format:Paperback
Language:English
ISBN:1796785350
ISBN13:9781796785357
Release Date:March 2019
Publisher:Independently Published
Length:54 Pages
Weight:0.25 lbs.
Dimensions:0.1" x 6.0" x 9.0"
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