The FDA's Quality Management System Regulation took effect, replacing 21 CFR Part 820 with alignment to ISO 13485:2016. It is a real shift in quality-system requirements. It does not fundamentally change your cybersecurity obligations.
The updated Premarket Cybersecurity Guidance reflects the transition with mostly administrative changes: new definitions for terms like TPLC and risk transfer, expanded glossary entries, and updated cross-references to ISO 13485. The cybersecurity bar did not move.
Treat QMSR as an opportunity to make your documentation terminology consistent, while keeping the same level of cybersecurity diligence.
If your vulnerability program was defensible last year, it is defensible under QMSR. The work now is aligning language, not rebuilding the security case.
Start with one device. We build the twin from documentation your quality system already produces, run AI discovery remotely, and show you the graph: the handful to fix, and the evidence for everything else.
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