Market Intelligence
2026 Regulatory Horizon: The QMSR Shift
Predictive intelligence on upcoming FDA and EU MDR divergences.
Overview
As the FDA harmonizes with ISO 13485 via the QMSR, the gap between US and EU compliance is narrowing yet deepening in complexity. This briefing analyzes the impact on legacy DHF structures.
Key Insights
QMSR Final Rule Impact
AI/ML Software Regulation Changes
Post-Brexit MHRA Divergence
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