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DAYS IN EFFECT
FDA QMSR — In effect since February 02, 2026
21 CFR Part 820 · ISO 13485:2016 incorporated by reference
21 CFR Part 820 · ISO 13485:2016 incorporated by reference
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AI-Powered Regulatory Compliance Platform for Medical Device Companies
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About VirtualBackroom.ai
Your AI-powered partner for medical device regulatory compliance.
VirtualBackroom.ai helps quality and regulatory professionals navigate complex healthcare regulations with intelligent audit simulations, real-time guidance, and multi-modal AI assistance.
Key Compliance Milestones
Track current and upcoming regulatory milestones, including:
- FDA QMSR — in effect since February 02, 2026
- EU IVDR - Class C (Notified Body Application) — May 26, 2026
- EU AI Act - High-Risk AI Systems — August 02, 2026
- EU MDR - Class III & Class IIb Implantable — December 31, 2027
Key Features:
- QMSR Audit Coach
- Gap Analysis Tools
- Citation Validation
- Regulatory Browser
- AI Assistant