Line items matched against FDA, Health Canada & TGA Australia recall data
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Product
GTIN
Class
Lot #
Qty
FDA
Health Canada
🇦🇺 TGA
🇪🇺 EU MDR
🇬🇧 MHRA
Vendor
Purchase Price
Install Date
Age
Warranty Expiry
Estimated Replacement Cost
Quarantine
Devices w/ Death Reports
—
of flagged devices
Devices w/ Injury Reports
—
of flagged devices
Devices w/ Malfunction Reports
—
of flagged devices
Top Classification
—
of flagged assets
Adverse Event Breakdown
Your devices with adverse-event history, current scope
🚨 Assets with FDA MAUDE reports (device-related deaths & injuries submitted to the FDA), covering the last 24 months of reports. Checked nightly. A report means someone filed a complaint about this device model somewhere — not that this specific unit is defective — so this is tracked separately from Recall Exposure and doesn't affect compliance/risk scoring.
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🚨 Adverse Event Exposure
Assets matched against FDA MAUDE — Death & Injury reports only
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Product
Manufacturer
Model #
Asset Class
Facility
Department
Events
Last Checked
🛡️ Manufacturer Quality Quadrant
Benchmarking medical device manufacturers by reliability and market presence
🟢 Leaders
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Top 25%
🔵 Strong Performers
—
Next 25%
🟡 Contenders
—
Middle 25%
🔴 Challengers
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Bottom 25%
📐 Classification Method
Y-axis — Reliability Recall score (0–100): 100 = zero recalls. Deductions: −8 per recall event, −5 per country affected. Manufacturers are then ranked against each other within this set.
Quadrant split Each axis divides at the median of the displayed set — always ~25% per quadrant. Ties in reliability broken by catalog size.
Loading manufacturer data…
LeadersStrong PerformersContendersChallengers· Ranking relative within displayed set · Hover dots for details
Top Manufacturers
View All
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Overall Recall Rate (Industry Average)
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Total Manufacturers Evaluated
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Total Recalls Analyzed (24 Months)
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Devices in Installed Base (Global)
🌍 Cross-Country Advance Warning
Devices recalled in 2+ non-US jurisdictions where the FDA has not yet acted
🔍 Manual Review Queue
Items that couldn't be auto-verified — check items to mark as reviewed
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Description
GTIN
Catalog #
Lot #
Message
Vendor
Invoice Date
Data Quality Trend
Average score over time (invoices & risk-scored assets)
Data Quality Breakdown
Items by verification status
Data Quality Grades
Invoice + asset-risk grade distribution
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Grade Breakdown
Invoices + risk-scored assets by compliance grade
🏭 Vendor Risk Ranking
Sorted by flagged & recalled item count
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Vendor
Invoices
Total Items
Flagged
Recalled
Adverse Events
Avg Score
📋 Scan History
All product scans from the mobile app
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Product / Description
GTIN
Lot #
Status
Recall
Vendor / Location
Scanned At
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Class:—
📦 Product Master Catalog
FDA GUDID reference data — 310K+ registered medical devices
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#
Brand / Description
UDI-DI
Manufacturer
Class
GMDN Term
Class:
🏥 Manufacturer → Brand / Device Type → Asset
Standardised device registry — GUDID + invoice processing + mobile scans · source=SCAN assets appear here automatically
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Asset Details
Expired
—
past warranty date
Expiring ≤30 days
—
urgent action needed
Expiring ≤90 days
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plan renewal
Valid
—
under warranty
Total Tracked
—
with warranty dates
Status:—
🔔 Warranty & Expiry Tracker
Capital/implant warranty dates and inventory item expiry dates — auto-populated from invoice processing · 90-day alerts generated nightly when the date is on file
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Brand / Model
Class
Manufacturer
Facility / Dept
Warranty / Expiry
Status
Days
Invoice Price
Est. Replacement Cost
Action
🌙 Nightly Recall & Warranty Job History
Runs at midnight UTC daily — checks all assets against FDA, Health Canada, and TGA
Run Date
Facility
Status
Assets Checked
Recalls Found
FDA
HC
TGA
Duration
Started At
Loading
Filter:—
🔬 Manufacturer → Brand → Product
Sourced from invoice line items + mobile scans
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⚡ MCP Agent Registry
All verification intelligence is delivered through Model Context Protocol (MCP) tools. Each regulatory data source registers as an independent agent — no hardcoded integrations. Agents are called in parallel per scan for maximum speed.
Registered Data Sources
Live agents & roadmap
12 agents
Agent
Data Source
Region
Status
Avg Latency
Total Calls
nightly_self_heal
Autonomous Job Recovery — detects nightly recall checks that failed or never ran, retries them automatically (checks daily 1am UTC, 1hr after the nightly job)
🌍 Global
Live
—
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fda_product_sync
openFDA Device UDI — Incremental Product Master Sync, keeps tblproductmaster current with newly published/changed FDA devices (runs weekly, Sunday 3am UTC)
🇺🇸 USA
Live
—
—
openFDA_drugs
FDA — Drug Recall & Enforcement Database
🇺🇸 USA
Live
142 ms
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gudid_lookup
FDA GUDID — Global Unique Device ID Database
🇺🇸 USA
Live
95 ms
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gs1_lookup
GS1 / UPC Item Database
🌍 Global
Live
89 ms
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health_canada
Health Canada — Drug & Device Recalls (33,563 records)
🇨🇦 Canada
Live
18 ms
—
claude_vision
Anthropic Claude AI — Label & Package Analysis
🌍 Global
Live
680 ms
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location_risk
GPS Anomaly Engine — Location Integrity Check
🌍 Global
Live
12 ms
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eu_mdr
EUDAMED — EU Medical Device Regulation Database (Vigilance module not yet public — mandatory May 2026, data access 2027)
🇪🇺 Europe
⏳ Pending
—
—
mhra_uk
MHRA — Medicines & Healthcare products Regulatory Agency (medicines recalls live · medical device FSNs via weekly GOV.UK feed)
🇬🇧 UK / 🇦🇪 Middle East
✓ Live
1,407
GOV.UK API
cdsco_india
CDSCO — Central Drugs Standard Control Organisation
🇮🇳 India
Roadmap Q4 2026
—
—
ede_uae
EDE — Emirates Drug Establishment
🇦🇪 UAE
Roadmap
—
—
tga_australia
TGA — Therapeutic Goods Administration
🇦🇺 Australia
✓ Live
9,585
TGA DRAC
who_pq
WHO Prequalification — Global Medicine Standards
🌍 Global
✓ Live
9,585
TGA DRAC
Agent Call Volume
From invoice processing pipeline
Verification Pipeline
How a scan flows through MCP agents
Per-item flow:
1. gs1_lookup → resolve GTIN to product name & manufacturer
2. gudid_lookup → check FDA device identifier registry
3. openFDA_drugs → screen against active drug recalls
4. health_canada → screen against Canadian advisories
5. mhra_uk → screen against MHRA UK medical device & medicine alerts
6. location_risk → flag GPS anomalies or suspicious supply chain locations
7. claude_vision → optional AI label analysis on uploaded images
All 7 live agents run in parallel via MCP tool calls, with results merged into a single compliance score.
🏥 Clients
All hospital/facility accounts
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Client
Type
Status
Invoices
Avg Score
Since
👤 Create Staff Account
Hospital-staff login for the mobile app (or dashboard) — same account system, tbladminuser
Email
Temporary Password
Full Name
Client
Facility (optional — blank = unlocked, all facilities)
Existing Staff Accounts
All hospital-staff logins across every client
—
Email
Full Name
Client
Facility
Status
Last Login
Created
🗂️
Service Registry
Manage and track all service contracts, maintenance schedules, and vendor service records for your medical equipment fleet.
🚀 Coming Soon
💼 Quotations
Upload a vendor quote to check its items against FDA / Health Canada / TGA / MHRA recalls and adverse-event history — before you buy. Quotes are checked once at upload; use "Re-check" for a fresh pull.
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Vendor
Quote #
Date
Valid Until
Items
Recalls
Class I
Adverse Events
Checked
Invoice Detail
Quotation
Upload Invoice
Import Asset List (CSV)
Product Detail
📖 How the Manufacturer Quality Quadrant Works
Y-Axis — Reliability Score (0–100)
Each manufacturer begins with a score of 100. The score is reduced based on two factors:
① Number of recalls over the last 18 months
② Geographic spread of those recalls
Manufacturers with fewer recalls and limited geographic impact receive higher scores. Manufacturers with frequent recalls affecting multiple countries receive lower scores.
Why these weightings?
The scoring has been calibrated to create meaningful separation between manufacturers while reflecting the severity of recurring and widespread recalls.
Examples:
✅ 0 recalls → 100
✅ 1 recall in 1 country → 87
⚠ 3 recalls across 5 countries → 51
A single localized recall has limited impact, while repeated recalls across multiple regulatory agencies indicate a broader quality concern. Manufacturers are then ranked relative to each other — those in the upper half of the chart have a better recall record than those below.
X-Axis — Market Presence Rank
Reflects the breadth of a manufacturer's registered medical device catalog (number of SKUs in the GS1/GUDID registry). The scale is log-normalised so a company with 10,000 products isn't disproportionately ranked against one with 500:
Manufacturers on the right side have a larger catalog presence than those on the left.
Quadrant Classification
Each axis is split at the median of the displayed set (not a fixed threshold), ensuring roughly equal groups in all four quadrants:
🟢 Leaders— Above-median reliability, below-median scale. Highly reliable specialists with a focused product range.
🔵 Strong Performers— Above-median reliability AND scale. Large manufacturers with a strong safety record.
🟡 Contenders— Below-median reliability, below-median scale. Smaller manufacturers with some recall activity relative to peers.
🔴 Challengers— Below-median reliability, above-median scale. Large-scale manufacturers with more notable recall history relative to peers.
Important Notes
📌 Tie-breaking: When two manufacturers have identical reliability scores (both with zero recalls), the one with a larger product catalog ranks higher — more registered products with zero recalls = stronger evidence of consistent safety.
📌 Relative ranking: Quadrant position reflects performance within this peer group, not an absolute quality rating. A "Challenger" may still have an excellent global safety record.
📌 Scope: Analysis covers the top 65 manufacturers by catalog size (minimum 30 registered products). Recall data updated nightly from FDA, Health Canada, TGA, and MHRA.
📌 Jurisdiction filter: Selecting a jurisdiction (FDA / HC / TGA) narrows the chart to only manufacturers with confirmed recalls in that region.
Methodology Note: The Manufacturer Quality Quadrant is a VerifyMed benchmarking model designed to help compare manufacturers using publicly available regulatory recall data and product catalog information. It is intended as a decision-support tool and should not be interpreted as a regulatory quality certification.