Posts Tagged ‘iso12485’

Getting QMSR Ready: Key Changes and Steps to Prepare for the February 2026 Deadline

Prepare Your Quality Management System for QMSR Compliance by February 2026

With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current Quality System Regulation (QSR) and align with ISO 13485:2016, marking a notable evolution in quality management practices for medical device production. Read more ยป