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karenparks
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iso 13485 certification (30th Jun 25 at 3:57am 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 iso 13485 certification date of ‘cessation of presumption of conformity of EN ISO 13485:2012 stated as 31 March 2019.


Hi friends! My name is Karenparks and I lead a team specializing in iso 22000 certification. Please feel free to share your thoughts and opinions related to this field. I am eager to learn from you all!
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