In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: ...

Published in December 2023, ISO/IEC 42001:2023 outlines rigorous requirements for establishing, implementing, and ...

ROCK ISLAND ARSENAL, Ill. – The Rock Island Arsenal-Joint Manufacturing and Technology Center has successfully completed its ISO 45001 audit, conducted by leading certification body AMTIVO.

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Glucotrack, Inc. gained ISO 13485:2016 certification, enhancing its commitment to quality in diabetes technologies.

Crossject successfully passes another ISO 13485 audit for sites in Dijon and Gray (France) Company is ramping up supply chain to prepare for commercialization in U.S.

FDA’s harmonization of the Quality System (QS) Regulation with ISO 13485 was long expected. It is welcomed by the global medtech companies, as other jurisdictions like the EU already use ISO 13485 as ...

The ISO 13485 documents toolkit gives users all the tools and direction they need to put the standard into practice. The materials, created by seasoned ISO consultants, are simple to use and ...

DIAGNOS Successfully Completes ISO 13485 / MDSAP Audit and receives its certification to move forward with FDA and Health Canada Aug. 20, 2024 9:45 AM ET DIAGNOS Inc. (DGNOF), ADK:CA ...