ISO 13485 Under Review as Industry Prepares for Potential Revision
June 25, 2025
You are not permitted to access this page. Please purchase membership to get full access to all articles.
Become a Member
Source: Management Systems World
The international standard for medical device quality systems, ISO 13485:2016, has entered its mandatory five-year systematic review, which concluded on June 5, 2025.
Most popular news
-
Updated ISO 21001 for Educational Management Moves Focus to Learners and SustainabilityOctober 15, 2025ISO 9001 Revision: Draft International Standard Published, Public Inquiry StartsSeptember 2, 2025Final Weeks Before Transition Deadline for ISO 27001: Act by End of OctoberOctober 8, 2025France Makes Nutri-Score Labeling Mandatory, But Excludes Traditional Food ProductsNovember 13, 2025ISO 17020 Reaches Final Global Vote toward 2026 ReleaseDecember 10, 2025Latest Part of ISO 19650 Series Covers Health and Safety Information in BIMSeptember 2, 2025EU: Public Consultation Opens on EN 18286, First Standard Supporting the AI ActNovember 13, 2025AIAG–VDA Release Harmonized SPC Yellow Volume for Automotive IndustryFebruary 4, 2026ISO/DIS 9001 Approved with Overwhelming Global Support, Reports SISDecember 3, 2025ISO 14001:2026 Final Draft Sets New Rules for Climate, Biodiversity and DocumentationDecember 10, 2025