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Partner Presentation | January 2026

VirtualBackroom.ai

AI-Powered Regulatory Logic Layer for Medical Device Compliance

"When AI automation handles the speed, VirtualBackroom.ai ensures the output is FDA-defensible."

QMSR Deadline

0

Days Remaining

February 2, 2026

The Problem: Real FDA Warning Letter

Envoy Medical | CMS # 718762 | November 2025 | Class III Implantable Device

Complaint Handling

21 CFR 820.198(a)

  • Complaints open 7+ months
  • Engineering deferred 3 meetings
  • No investigation completed

CAPA System

21 CFR 820.100(a)

  • CAPAs closed without HHE
  • No product impact assessment
  • Same failures repeated

Risk Analysis

21 CFR 820.30(g)

  • Risk file not updated since 2017
  • Inconsistent severity ratings
  • New hazards not identified

The Pattern: Siloed Risk

FDA found "ongoing systemic issues" — Complaint system knew about infections, CAPA system knew about cleanroom issues, but the Risk File didn't know about either.

The Defensible Flow

NCR → CAPA → Risk File: What FDA Actually Expects

COMPLAINT / NCR
MDR trigger check, Repeat signal detection, Auto-assign owner
TRIAGE (24-48h)
Reportable? Repeat signal? Investigation owner?
INVESTIGATION
Root cause vs symptom, Product impact, Health hazard eval
CAPA DECISION
CAPA or correction? Risk justification? Effectiveness criteria?
RISK FILE UPDATE
New hazard → FMEA, Severity/occurrence change, Document decision
EFFECTIVENESS
Recurrence stopped? Control implemented? Close with evidence

The Solution: Integration Vision

AI handles the speed. Domain expertise ensures defensibility.

Artemis

AI Automation Layer

  • Auto-categorize complaints
  • Surface repeat signals
  • Draft root cause analysis
  • Generate CAPA action items
  • Track effectiveness metrics

VirtualBackroom.ai

Regulatory Logic Layer

  • Validate reportability decisions
  • Confirm root cause vs symptom
  • Enforce risk file linkage
  • FDA-defensibility sign-off
  • Audit trail completeness

Multi-Model AI Architecture

Powered by OpenRouter with intelligent model selection

Gemini 3.1 Pro Gemini 3.1 Pro Gemini 3.1 Pro Gemini 3.1 Pro Gemini 3.1 Pro Gemini 3.1 Pro Gemini 3.1 Pro Gemini 3.1 Pro
1M+

Token Context Window

8

AI Expert Council

6

Fallback Providers

24/7

Availability

Fallback Chain: OpenRouter → Gemini → OpenAI → Anthropic → Perplexity → Local

Platform Capabilities

Production-ready features for regulatory compliance

AI Gap Analysis

Upload QMS documents for AI analysis against QMSR requirements

Council Mode

11 AI experts provide multi-perspective regulatory analysis

Mind Map Generator

AI-powered diagrams from audit transcripts

Audit Coach

Interactive FDA, ISO, MDR audit simulations

Citation Check

QMSR citation validation with transition warnings

PDF Export

Professional compliance reports with scoring

Live Demo

See VirtualBackroom.ai catch compliance gaps in real QMS documents

Upload the demo CAPA record and watch VirtualBackroom.ai identify:

Missing Product Impact Assessment
Missing Health Hazard Evaluation
Risk File Not Updated
Open Gap Analysis Tool

Next Steps

Partner with VirtualBackroom.ai

Ready to ensure FDA-defensible compliance?

  • Integration partnership
  • White-label licensing
  • API access
  • Custom model training
  • Enterprise deployment
  • Consulting services
Contact: neel@qms.coach Back to Demo Page
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