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.
Every user journey, the dashboard, and the AI Management Console — walked end to end.
A single platform for biomedical engineers, field service technicians, and calibration specialists — connecting equipment, maintenance, calibration, and compliance across a hospital network.
VP/Director of Biomedical Engineering, Chief Medical Officer, Chief Operations Officer, and every biomed engineer, technician, and calibration specialist on the floor.
Biomedical teams manage the device register, maintenance schedules, calibration records, and recall remediation — unlimited users, no per-seat cost.
The Director of Biomedical Engineering, CMO, or COO queries equipment uptime, maintenance backlog, calibration compliance, and recall exposure in plain English.
Purpose-built data models, workflows, and views — generated by the VeloIQ™ framework and refined for the vertical.
The FHIR R4 Device resource — UDI, serial/lot number, risk classification, criticality, warranty, and lifecycle status, scoped to a location and hospital network.
FHIR R4 DeviceMetric channels — heart rate, SpO2, flow rate, pressure, battery level, and runtime hours per device, with operational status.
Recurring PM schedules by device, and work orders (preventive, corrective, calibration, recall-remediation, decommission) with Part 11 e-signatures.
Calibration events against a reference standard, with pass/fail/adjusted results and an automatically-derived measured-vs-reference deviation.
FDA and manufacturer hazard/recall notices matched per affected device, with remediation status and audit-trail-required corrective action.
Joint Commission, FDA, and internal inspection events by location, with findings and corrective-action-due tracking.
VeloIQ™ MedDevice Guard ships as a complete, working application — not a template you still have to build.
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.
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).
One veloiq run and the full application is live: REST API, React frontend, admin back-office, and AI console — all on your own infrastructure.
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.
Measurable outcomes for every role — from the biomed technician on the floor to the COO.
Status, criticality, and warranty across every device — no more discovering an expired warranty or overdue PM from a failed inspection.
Preventive maintenance schedules with next-due tracking, and auto-escalating work order priority for life-support devices.
Every calibration's deviation from reference is derived automatically, so out-of-tolerance equipment surfaces before it affects patient care.
Every hazard recall matched to its affected devices individually, with remediation status tracked device-by-device — not a spreadsheet.
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.
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.
From the device asset dashboard to calibration records, work orders, and recall matches — every screen generated by VeloIQ™, refined for biomedical engineering.
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).
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.
| Area | Standard | Models mapped |
|---|---|---|
| Device asset register | HL7 FHIR R4 Device | UDI, status, type, manufacturer, model/lot/serial number — mapped to Device |
| Device telemetry | HL7 FHIR R4 DeviceMetric | Category, operational status, unit, measured value — mapped to DeviceMetric |
| Quality management system | ISO 13485:2016 | Maintenance, calibration, nonconforming-product control, and inspection clauses — mapped across Maintenance, Calibration, and Compliance modules |
| Electronic records/signatures | FDA 21 CFR Part 11 | Performer/verifier signature fields on WorkOrder and CalibrationRecord |
Every VeloIQ™ vertical application is versioned source code — not a locked SaaS. Fork, extend, integrate, or white-label.
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.
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.
Add custom business logic in custom_api.py, override page-config templates per model:action, or add SQLAdmin views for advanced administration.
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 Import — learn about IQVigilant capabilities
Get in touch with the VeloIQ™ team to discuss deployment, customization, and licensing.