karenparks87687 Full Member
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| | iso 13485 certification (11th Aug 25 at 3:10am UTC) | | ISO 13485 certification 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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Hi friends! My name is Karenparks and I lead a team specializing in iso 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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