VirtualBackroom.ai
AI-Powered Regulatory Compliance Platform for Medical Device Companies
Platform Overview
VirtualBackroom.ai is a comprehensive AI-powered regulatory compliance platform designed specifically for medical device companies navigating complex healthcare regulations.
Mission
To simplify regulatory compliance workflows by providing intelligent audit simulations, real-time guidance, and multi-modal AI assistance that helps quality and regulatory professionals work more efficiently.
Technology
Built with multi-provider AI integration (Gemini, OpenAI, Anthropic, Perplexity) featuring intelligent fallback mechanisms to ensure reliable responses for your regulatory questions.
Key Value Proposition
VirtualBackroom.ai acts as your virtual regulatory affairs consultant, available 24/7 to answer questions, validate citations, simulate audits, and guide you through complex compliance requirements.
QMSR Transition Support
FDA Quality Management System Regulation (QMSR)
The FDA's new Quality Management System Regulation (QMSR) replaces the current 21 CFR Part 820 Quality System Regulation (QSR) by incorporating ISO 13485:2016 by reference.
Compliance Deadline
February 2, 2026
21 days remaining
What Changes with QMSR?
Incorporated by Reference
ISO 13485:2016 becomes the foundation, replacing most QSR subparts with "[Reserved]" designations.
New FDA-Specific Sections
Two new sections require special attention: §820.35 (Control of Records) and §820.45 (Device Labeling and Packaging Controls).
QMSR Tools Available
- QMSR Readiness Snapshot - Self-assessment questionnaire aligned to ISO 13485:2016 subclauses
- QMSR Audit Coach - Interactive audit simulations with AI-powered feedback
- QSR-QMSR Structure Comparison - Side-by-side mapping of old vs. new regulatory structure
- Definition Hierarchy - 13 comprehensive FDA-specific terms with categorization
- Citation Validation - Validates QMSR sections, ISO 13485 clauses, legacy QSR, MDR, and UDI citations
Upcoming Regulatory Deadlines
Key compliance deadlines for medical device manufacturers across global markets. Plan ahead to ensure smooth transitions.
FDA QMSR
USQuality Management System Regulation replaces 21 CFR Part 820
EU IVDR - Class C
EUTransition deadline for Class C IVD devices under IVDR 2017/746
EU IVDR - Class B/A Sterile
EUTransition deadline for Class B and Class A sterile IVD devices under IVDR 2017/746
EU MDR - Class IIb/IIa Legacy
EUTransition deadline for Class IIb non-implantable and Class IIa devices under EU MDR 2017/745
UKCA Marking Extension
UKExtended deadline for UKCA marking requirement for medical devices in Great Britain
EU MDR - Class I Legacy
EUTransition deadline for Class I sterile and measuring devices under EU MDR 2017/745
FDA UDI - Class I
USUDI compliance deadline for Class I and unclassified devices
Health Canada MDSAP
CanadaMDSAP audit required for medical device licenses in Canada
Regional Legend
US United States (FDA) EU European Union (MDR/IVDR) UK United Kingdom (MHRA) Canada Health Canada
Core Features
QMSR Audit Coach
Interactive audit simulations that test your knowledge of regulatory requirements. Get AI-powered feedback on your responses and track your progress over time.
- Scenario-based audit questions
- Real-time AI feedback
- Performance tracking and history
QMSR Readiness Snapshot
Comprehensive self-assessment questionnaire with 50 questions aligned to ISO 13485:2016 subclauses covering all major QMS areas.
- Clause 4-8 coverage
- Gap identification
- Prioritized action items
Citation Validation
Intelligent citation validation supporting multiple regulatory formats with cross-reference mapping.
- QMSR sections (§820.x)
- ISO 13485 clauses
- MDR (21 CFR 803) and UDI (21 CFR 830)
Regulatory Browser
Access and explore 16+ regulatory standards including ISO, FDA, and EU MDR with cross-references between equivalent sections.
- Full-text search
- Cross-standard mapping
- Citation linking
Regulatory Assistant
AI-powered conversational assistant for regulatory compliance questions with citation suggestions for your documentation.
- Natural language queries
- Context-aware responses
- Citation recommendations
Global Regulatory Monitor
Real-time monitoring of regulatory news and updates from 36 regulatory bodies across 6 major regions worldwide.
- Live news aggregation
- Trending topics extraction
- Alert notifications
Getting Started
Create Account
Register for a free account to access all platform features and save your progress.
Take Assessment
Complete the QMSR Readiness Snapshot to identify gaps in your current QMS compliance.
Practice & Learn
Use the Audit Coach simulations and Regulatory Browser to build compliance expertise.
Pro Tip
Toggle between Simple Mode (3 core features) and Pro Mode (all advanced tools) using the button in the navigation bar to customize your experience.
Regulatory Knowledge Framework
VirtualBackroom.ai incorporates a comprehensive reference map of global medical device regulations:
Core Regulatory Authorities
| FDA (US) | 21 CFR Part 820 (QMSR), 21 CFR Part 803 (MDR) |
| EU | MDR (2017/745), IVDR (2017/746) |
| Canada | Health Canada CMDCAS |
| Australia | TGA |
| Japan | PMDA |
| China | NMPA |
| Brazil | ANVISA |
| Korea | MFDS |
Global Standards
| ISO 13485 | Quality Management Systems |
| ISO 14971 | Risk Management |
| IEC 62304 | Software Lifecycle |
| IEC 60601-1 | Electrical Safety |
| ISO 10993 | Biocompatibility |
| ISO 11135 | Sterilization |
Important Disclaimers
Pre-Release Status
This is a pre-release prototype for training and advisory purposes only. Do not rely on this tool for official compliance decisions.
Not Regulatory Advice
Information provided is for educational purposes and does not constitute formal regulatory or legal advice. Consult qualified professionals for official guidance.
Data Privacy
DO NOT upload or paste patient data, protected health information (PHI), personally identifiable information (PII), or confidential trade secrets.
Assessments Are Self-Reported
QMSR Readiness Snapshots and gap analyses are self-reported assessments and are not a substitute for formal internal audits or notified body reviews.