The Quality Management System Regulation (QMSR) is now in effect, replacing the legacy QSR. For cybersecurity programs, the most material shifts are scoped record requirements and tighter alignment with ISO 13485 design and risk processes.
What to update now: your design history file index, security risk management plan references, and CAPA templates that previously pointed at 21 CFR 820 sub-parts. Most controls (design inputs/outputs, V&V, supplier controls) map cleanly — only the citation language and a few records change.
Source
FDA QMSR final rule
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