Articles tagged with “device-manufacturers”

FDA QMSR & ISO 13485: Key Changes Effective 2026

Analyze the FDA Quality Management System Regulation (QMSR) effective Feb 2, 2026. Learn how ISO 13485:2016 incorporation impacts medical device compliance.

50 min read

2/27/2026

fda qmsr iso 13485 medical device regulation 21 cfr part 820 quality management regulatory compliance fda inspection device manufacturers