Transition of ISO 13485: 2003 to ISO 13485:2016. The changes and its application: A Case Study: The Practical Guide (Paperback) (ISBN-13: 9781796785357)

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 ISO 13485:2003 will be withdrawn on February 28th, 2019.This book listed the requirements in ISO 13485:2003 and ISO 13485:2016.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.

Author: Kingster
ISBN-10: 1796785350
ISBN-13: 9781796785357
Publisher: Independently Published
Language: English
Published: 03/01/2019
Pages: 54
Format: Paperback
Weight: 0.20lbs
Size: 9.02h x 5.98w x 0.13d