Hurry Up! FDA’s Quality System Harmonization with ISO 13485 by Markus Gee, director of Life Sciences Division, Axeon, was given on November 12, 2025, in Salt Lake City at the 2025 May Brown Utah Life Sciences Summit presented by BioUtah.
For years, the medical device industry has been closely watching to see when harmonization between the FDA’s Quality System Regulation (QSR) and ISO 13485 would come to fruition. On January 31, 2024, the FDA released its Final Rule for the new Quality Management System Regulation (QMSR). The new QMSR is the result of aligning the current good manufacturing practice (cGMP) requirements of the FDA’s QSR with the international consensus standard for medical device quality management systems (ISO 13485), with an effective date for medtech companies of February 2, 2026. This significant step toward harmonization has implications for industry.
