Everything clinical engineering needs, on one system of record
CogniQuip brings device inventory, the full work-order lifecycle, PM and calibration, recalls, and IoMT security into a single platform — with a 21 CFR Part 11 audit trail running underneath all of it.
Multiple work-order types, one consistent flow
From corrective and preventive to calibration, incoming inspection, and recall remediation, every work-order type runs through a single engine — with work items, parts, labor, and attached PM procedures captured as the work happens.
- Assignment, scheduling, and status across the fleet
- Parts, labor, and cost on every order
- Batch create, close, and cancel in WO Operations
A complete, structured record for every device
Each device carries its UDI, FDA classification, manufacturer and model, facility and department, plus financial, warranty, regulatory, IT/network, and documentation details — and a full, time-stamped history.
- UDI + FDA classification on every record
- Financial, warranty, regulatory, and IT/network tabs
- Bulk CSV import and UDI / barcode scanning
Scheduled PM with audit-proof calibration
Set preventive-maintenance intervals per model, department, or asset; track PM compliance and overdue work on the dashboard; and auto-generate the right work orders — following manufacturer recommendations, with CMS/Joint Commission lead-time rules built in. Calibration records become immutable once signed.
- Configurable intervals from manufacturer recommendations & regulatory lead-time rules
- PM-compliance and overdue tracking
- Immutable calibration records (21 CFR Part 11)
- Reusable, section-level PM procedure library
Match recalls to your fleet and act on them
CogniQuip ingests FDA recall and enforcement data and matches it against the devices you actually own, so field actions turn into tracked remediation work orders — with the evidence retained.
- FDA recall and enforcement matching by device
- Remediation tracked as work orders
- Records retained for MDR (21 CFR 803)
Fleet-level vulnerability visibility
The CISA KEV catalog of actively-exploited vulnerabilities is correlated to your fleet by manufacturer, with live NVD CVE lookup, so you can prioritize by severity and drive remediation — security and clinical engineering on the same record. CogniQuip is integration-ready for the IoMT security platforms you already run (Palo Alto Medical IoT Security, Claroty, Armis).
- CISA KEV fleet correlation + live NVD CVE lookup
- Vulnerabilities correlated to your fleet by manufacturer
- Prioritize by severity; remediate as work orders
- IoMT security-tool integration-ready
The numbers leadership asks for, at a glance
Dashboards surface open work orders, PM compliance, work-order mix by type and status, devices by classification, and recall summaries — exportable for leadership and inspections.
- Open WOs, PM compliance, and overdue at a glance
- WO by type and status; devices by classification
- Exportable reports for review and audit
An enterprise foundation under every module
21 CFR Part 11 by design
Immutable calibration records and a complete, attributed change log on every record, with electronic signatures on the roadmap.
Multi-tenant & role-based
Tenant isolation with PostgreSQL RLS and RBAC, with SSO and MFA through your identity provider (AWS Cognito / SAML / OIDC).
Connected to the sources of truth
openFDA, NVD, and the CISA KEV catalog feed the platform automatically, and AccessGUDID provides UDI lookups on demand; ticketing/ITSM (ServiceNow) and IoMT security-tool integrations are ready to connect.
Cloud or on-premise
Designed to run on AWS, with Azure and self-hosted/on-prem container options to fit your security posture.
What's shipped, ready to connect, and coming next
We build with our design partners and label every capability honestly — so you always know what's available today, what's ready to integrate, and what's still in development.
Team messaging & collaboration
Direct and group messaging so clinical engineers, BMETs, and requesters coordinate without leaving the platform.
Project management
Plan capital projects, equipment rollouts, and recall campaigns on a Kanban board with linked devices and documents.
Contract management
Track service, PM, and vendor contracts — scope, terms, costs, and expirations — linked to the devices and vendors they cover, with SLA/MSA documents.
Ticketing / ITSM integration
Verified connector to ServiceNow and similar ITSM systems — data sync available to design partners.
IoMT security-tool integration
Integration-ready for Palo Alto Medical IoT Security, Claroty, Armis, and Medigate — ingest device findings and reconcile them to your inventory.
Electronic signatures
21 CFR Part 11 electronic signatures bound to the record, capturing signer name, time, and meaning.
See CogniQuip on your equipment
A walkthrough tailored to your device fleet — compliance, calibration, and all. No obligation.