• I.S. EN ISO 13485:2016&LC:2016&AC:2018

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    National Standards Authority of Ireland

    Most Recent

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Add To Cart