Healthcare  ·  Built on VeloIQ™ + IQVigilant  ·  Ready for Your Vertical

VeloIQ™ MedDevice Guard — Biomedical Equipment Lifecycle & Maintenance Compliance in One View

Full device asset register built on the HL7 FHIR R4 Device and DeviceMetric resources — preventive maintenance scheduling, calibration records with automatic deviation tracking, FDA/manufacturer hazard recall matching per device, and Joint Commission/FDA inspection readiness. 21 CFR Part 11-aligned e-signatures on every work order and calibration.

HL7 FHIR R4ISO 13485FDA 21 CFR Part 11

A guided tour of MedDevice Guard

Every user journey, the dashboard, and the AI Management Console — walked end to end.

From the biomed shop floor to the executive suite — one platform

A single platform for biomedical engineers, field service technicians, and calibration specialists — connecting equipment, maintenance, calibration, and compliance across a hospital network.

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Who it’s for

VP/Director of Biomedical Engineering, Chief Medical Officer, Chief Operations Officer, and every biomed engineer, technician, and calibration specialist on the floor.

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Unlimited-user operations layer

Biomedical teams manage the device register, maintenance schedules, calibration records, and recall remediation — unlimited users, no per-seat cost.

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AI analytics for the decision-maker

The Director of Biomedical Engineering, CMO, or COO queries equipment uptime, maintenance backlog, calibration compliance, and recall exposure in plain English.

Every module a biomedical engineering team needs, pre-built

Purpose-built data models, workflows, and views — generated by the VeloIQ™ framework and refined for the vertical.

Device Asset Register

The FHIR R4 Device resource — UDI, serial/lot number, risk classification, criticality, warranty, and lifecycle status, scoped to a location and hospital network.

Device Telemetry

FHIR R4 DeviceMetric channels — heart rate, SpO2, flow rate, pressure, battery level, and runtime hours per device, with operational status.

Preventive Maintenance & Work Orders

Recurring PM schedules by device, and work orders (preventive, corrective, calibration, recall-remediation, decommission) with Part 11 e-signatures.

Calibration Records

Calibration events against a reference standard, with pass/fail/adjusted results and an automatically-derived measured-vs-reference deviation.

Hazard Recall Management

FDA and manufacturer hazard/recall notices matched per affected device, with remediation status and audit-trail-required corrective action.

Inspection Readiness

Joint Commission, FDA, and internal inspection events by location, with findings and corrective-action-due tracking.

Deployable on day one

VeloIQ™ MedDevice Guard ships as a complete, working application — not a template you still have to build.

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Pre-bundled & seeded

Arrives with realistic sample data (15 devices, 93 telemetry readings, 34 work orders, 20 calibration records, 2 active hazard recalls) plus a clean production-ready database. Explore instantly, then switch when you go live.

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Pre-configured NL analytics

6 pre-configured NL chats with 34 sample sentences — equipment inventory, maintenance & work orders, calibration & compliance, and recall & inspection compliance (native), plus fleet analytics and inspection-readiness AI assistants (agentic).

Runs out of the box

One veloiq run and the full application is live: REST API, React frontend, admin back-office, and AI console — all on your own infrastructure.

Tested & verifiable

Automated smoke, regression, and licensing suites ship with the app — including a full regression that executes every native NL sentence and asserts real answer content.

Turn biomedical equipment compliance into a durable operational advantage

Measurable outcomes for every role — from the biomed technician on the floor to the COO.

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Fleet-wide equipment visibility

Status, criticality, and warranty across every device — no more discovering an expired warranty or overdue PM from a failed inspection.

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Proactive maintenance

Preventive maintenance schedules with next-due tracking, and auto-escalating work order priority for life-support devices.

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Calibration confidence

Every calibration's deviation from reference is derived automatically, so out-of-tolerance equipment surfaces before it affects patient care.

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Recall exposure, closed the loop

Every hazard recall matched to its affected devices individually, with remediation status tracked device-by-device — not a spreadsheet.

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Audit-ready, always

21 CFR Part 11 e-signatures on work orders and calibrations, plus Joint Commission/FDA inspection tracking — audit readiness is a query, not a scramble.

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The fleet's digital bodyguard

IQVigilant's Exception Management watches the highest-consequence assets — life-support devices with open work orders — for anomalies, with a 1-user free-tier license included.

The Biomedical Engineering Experience

From the device asset dashboard to calibration records, work orders, and recall matches — every screen generated by VeloIQ™, refined for biomedical engineering.

Device record with UDI, risk class, criticality, and related metrics/work orders
Device — UDI, risk class, criticality, and every related metric, work order, and calibration
Work order record with status workflow stage bar
Work order — status workflow, priority, and Part 11 e-signature fields
Calibration record with measured value, reference value, and derived deviation
Calibration record — measured/reference values and the derived deviation
Hazard recall notice record with status workflow and affected devices
Hazard recall notice — status workflow and matched affected devices
Maintenance schedule record with calendar view
Maintenance schedule — frequency, next-due date, calendar-view scheduling
MedDevice Guard dashboard with device metric, work order, and calibration analytics
Dashboard — device metrics, work orders, and calibration records at a glance

Natural Language-Powered Biomedical Analytics

Ask questions in plain English. Get bar charts, pie charts, donuts, bubble charts, area charts, and boxplots — no SQL required. 5 pre-built NL chats for equipment inventory, maintenance & work orders, and calibration & compliance (native), plus fleet analytics and inspection-readiness AI assistants (agentic).

Equipment inventory analytics chart generated by NL query
Equipment inventory — device type, criticality, and risk class from plain-English queries
Maintenance and work orders analytics chart
Maintenance & work orders — status trends and per-device backlog
Calibration and compliance analytics chart
Calibration & compliance — deviation distribution and recall remediation status

HL7 FHIR R4, ISO 13485 & 21 CFR Part 11 — the standards that power the industry

Data models and metadata that speak your industry’s language — because compliance and interoperability start with the schema. See the full mapping in the app's STANDARDS.md.

AreaStandardModels mapped
Device asset registerHL7 FHIR R4 DeviceUDI, status, type, manufacturer, model/lot/serial number — mapped to Device
Device telemetryHL7 FHIR R4 DeviceMetricCategory, operational status, unit, measured value — mapped to DeviceMetric
Quality management systemISO 13485:2016Maintenance, calibration, nonconforming-product control, and inspection clauses — mapped across Maintenance, Calibration, and Compliance modules
Electronic records/signaturesFDA 21 CFR Part 11Performer/verifier signature fields on WorkOrder and CalibrationRecord

Built on VeloIQ™. Tailored to your hospital network.

Every VeloIQ™ vertical application is versioned source code — not a locked SaaS. Fork, extend, integrate, or white-label.

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Modular data models

Each module is a self-contained VeloIQ™ unit with its own models.py, generated GUI views, and REST API. Add or remove modules as your needs evolve.

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Extension packages

Bring in IQVigilant for NL analytics and exception alerts, and Advanced Development for page-config templates, business rules, and data import — configured declaratively in veloiq.toml.

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Custom endpoints & views

Add custom business logic in custom_api.py, override page-config templates per model:action, or add SQLAdmin views for advanced administration.

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Bring your own database

Switch from the shipped SQLite to PostgreSQL, MySQL, or Snowflake with a single connection string change. Schema migrations are tracked via Alembic.

AI-ready with 1-User Natural Language · 10 Exception Alerts · UI Configuration, Dynamic Business Rules & Data Importlearn about IQVigilant capabilities

Ready to bring VeloIQ™ MedDevice Guard to your hospital network?

Get in touch with the VeloIQ™ team to discuss deployment, customization, and licensing.