philipwatson
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| | ISO 13485 CERTIFICATION (9th May 24 at 5:32am UTC) | | ISO 13485:2016 is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD and IVDD. EN ISO 13485:2012 is now updated as ISO 13485:2016, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019.
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Hey everyone! I am a consultant who specializes in iso certification. This page will be dedicated to sharing my experiences and learning from others in this field. Please feel free to share your own stories and perspectives! Thanks for visiting! |
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