One system of record for every medical device you maintain.
CogniQuip unifies device inventory, work orders, preventive maintenance, calibration, recalls, and IoMT security — with a 21 CFR Part 11 audit trail built in. Purpose-built for clinical engineering, not retrofitted from generic asset software.
- Multiple work-order types in one engine
- Configurable-interval PM with immutable calibration records
- Live FDA recall + CVE feeds correlated to your fleet
Built for the standards your program is audited against
Your device program shouldn't live in five systems and a spreadsheet.
Clinical engineering teams stitch together a legacy CMMS, vendor portals, calibration logs, recall emails, and security spreadsheets. CogniQuip pulls device inventory, work orders, PM, calibration, recalls, and IoMT risk into one platform — so the record is always complete and the evidence is ready before the auditor asks.
- One structured record per device — nameplate to disposal
- Every work-order type in a single engine
- Compliance evidence captured as the work happens
Everything HTM needs, on a single system of record
No bolt-ons, no swivel-chairing between tools. From the loading dock to decommissioning, every device and every work order lives in one place.
Device inventory & lifecycle
Every device with its UDI, FDA classification, model, location, contracts, and full service history.
One work-order engine
Corrective, preventive, calibration, incoming inspection, recall, and more — all in a single flow.
PM & calibration
Configurable PM intervals, PM-compliance tracking, and immutable calibration records.
IoMT security
Your fleet correlated with live CVE and CISA KEV feeds — not a separate, disconnected tool.
A complete, structured record for every device
Each device carries its UDI, FDA class, manufacturer and model, facility and department, plus financial, warranty, regulatory, and IT/network details — and a full, time-stamped service history.
- UDI + FDA classification on every record
- Manufacturer / model, facility / department, contracts
- Bulk CSV import and UDI / barcode scanning
Multiple work-order types, one engine
From corrective and preventive to calibration, incoming inspection, and recall remediation, every work-order type runs through one consistent flow — with work items, parts, labor, and attached PM procedures.
- Work items, parts, and labor captured as work happens
- Attach reusable PM procedures to any order
- Batch create, close, and cancel in WO Operations
Stay ahead of PM — and keep calibration audit-proof
Schedule preventive maintenance by risk, track PM compliance and overdue work, and auto-generate the right work orders. Calibration records are immutable once signed.
- PM-compliance and overdue tracking on the dashboard
- Immutable calibration records (21 CFR Part 11)
- Reusable, section-level PM procedure library
See device risk before it becomes an incident
CogniQuip correlates your fleet with the CISA KEV catalog of actively-exploited vulnerabilities by manufacturer, with live NVD CVE lookup — so you can prioritize by severity and drive remediation as work orders.
- 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 — Palo Alto, Claroty, Armis
The audit trail is already written by the time the auditor arrives
CogniQuip treats records as evidence. Calibration is immutable, every change is logged, and the reports inspectors ask for are a click away — so compliance is a by-product of doing the work, not a separate scramble.
21 CFR Part 11 audit trail
Every change is logged with user, timestamp, and reason, and calibration records are immutable once signed — with electronic signatures on the roadmap.
Recall & MDR workflow
Match FDA recalls to your fleet and drive remediation through tracked work orders.
Standards-aligned safety
PM and electrical-safety testing aligned to IEC 62353 and AAMI EQ56 / EQ89.
- Calibration recorded14:02:11Zj.rivera (BMET)
- Result verified & attributed14:02:14Zj.rivera (BMET)
- Reviewed & approved15:20:48Zs.okafor (CE Mgr)
- Record locked15:20:48Zsystem
The authoritative feeds, ingested automatically
CogniQuip pulls device, recall, and vulnerability data from the systems clinical engineering already trusts — so your records stay current without manual lookups.
The details that make it usable on the floor
UDI & barcode scanning
Scan a device on the floor to pull its record or raise a request — no hunting through screens.
Bulk CSV import
Stand up devices, models, classifications, and PM procedures fast with guided imports.
Contract management
Track service, PM, and vendor contracts — scope, terms, costs, and expirations — linked to the devices and vendors they cover.
Dashboards & reports
Open WOs, PM compliance, WO by type and status, devices by class, recall summary — at a glance.
Authoritative data feeds
openFDA, NVD, and the CISA KEV catalog feed the platform automatically; AccessGUDID provides UDI lookups on demand.
Team messaging
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.
RBAC & audit trail
Role-based access with a complete, queryable 21 CFR Part 11 change log on every record.
Built for the gaps the market leaders left open
Clinical engineering and HTM teams have made do with software that was never designed for them. These are the gaps we set out to close.
Cybersecurity is bolted on after the fact
Most CMMS treat IoMT security as a separate tool, so clinical engineering and security work from different inventories — and findings rarely become tracked work.
Vulnerability intelligence is native. Your fleet is correlated to live CVE and CISA KEV data, and the platform is built to ingest your security tools' findings and drive remediation as work orders.
Generic asset software, retrofitted to healthcare
Many market leaders began as facilities or IT asset management and bolt medical-device concepts on top of a generic core.
CogniQuip is HTM-native. UDI/GUDID identity, FDA classification, IEC 62353 safety, and recall matching are first-class — not add-ons.
Compliance evidence is reconstructed at audit time
Legacy tools record work but not as tamper-evident, survey-ready proof — so every Joint Commission or CMS visit becomes a scramble.
Evidence is a by-product of the work: immutable calibration, an attributed 21 CFR Part 11 change log, and inspection-ready reports a click away.
Recall-to-fleet matching is left to spreadsheets
Even leading platforms expect someone to read FDA notices and cross-reference thousands of assets by hand.
CogniQuip matches FDA recall and enforcement data to the devices you actually own — with confidence grading and a human-approved remediation work order.
Months of data cleanup before any value
Traditional migrations stall on dirty legacy data and long implementation projects.
Barcode/UDI scanning pulls official device identity and guided bulk import is designed to stand up clean inventory in weeks. Clean data is the output, not the prerequisite.
Built for giant IDNs, not your team
Market-leading suites are priced and scoped for the largest health systems, leaving 50–300-bed hospitals and ISOs with oversized, clunky tooling.
CogniQuip is purpose-built for mid-size clinical-engineering teams — modern, fast, and responsive on the devices your team already uses, without enterprise bloat.
The platform at a glance
Built for every role on the clinical-engineering team
One platform that gives directors, managers, technicians, compliance, and security the view each of them needs.
Clinical Engineering Directors
Program-wide visibility into backlog, PM compliance, cost, and risk across every site.
BMET Managers
Assign, schedule, and balance work across the team — and batch-manage orders without spreadsheets.
BMETs & technicians
A clear queue, full device history, and procedures in hand, with UDI scanning on the floor.
Compliance Officers
Audit-ready records, immutable calibration, and a complete change log when inspectors arrive.
IoMT Security Analysts
Device-level vulnerability visibility correlated with live CVE feeds and tracked to remediation.
Bring CogniQuip to your clinical-engineering team
Tell us about your fleet and we'll show you exactly how CogniQuip handles your work orders, calibration, and compliance.
- A walkthrough tailored to your device fleet
- Honest answers on compliance and migration
- No obligation, no aggressive sales motion