12/5/2023 0 Comments Iso 13485:2016The next review is due in 2024 so a revised standard is unlikely before 2026. So, no changes then to the standard itself and no alignment with the High-Level Structure (or Harmonized Structure). The ISO website currently shows the ISO 13485 standard as ‘confirmed’ in January 2020. An 'Informative' Amendment that must not be ignored
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