5/29/2023 0 Comments Get iso 13485 certificationThe harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 20, respectively. Harmonization of standards allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation. 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. 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. ISO 13485 Certification in Singapore About ISO 13485 standard ISO 45001 Migration Lead Auditor Training.
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