Medical device field service software where the service report and the complaint record are one record
Medical device field service is the regulated work of installing, maintaining, repairing and updating devices at customer sites, where each service report is potential complaint evidence rather than a closed ticket. 21 CFR Part 820 became the Quality Management System Regulation on February 2, 2026, incorporating ISO 13485:2016, while Part 803 still requires device related deaths and serious injuries to be reported within 30 calendar days. Neurobird keeps the service history, the calibration evidence and the complaint decision on one chain per device.
Neurobird Medical Device Field Service in short
- Screen every service report against complaint criteria at the moment it is written, not at quarterly review
- Carry the UDI on the service record so field data joins to the device, the lot and the software version
- Keep calibration certificates for field test equipment attached to the visits that used it
- 820 21 CFR Part 820 became the Quality Management System Regulation on February 2, 2026, incorporating ISO 13485:2016 by reference. Servicing records are part of that quality system rather than outside it. eCFR, 21 CFR Part 820
- 803 Medical device reporting: a manufacturer files within 30 calendar days of learning of a device related death or serious injury, and within 5 work days when remedial action is needed to prevent a substantial public health risk. eCFR, 21 CFR Part 803
- Pricing runs 110 to 420 US dollars per month across 3 tiers. Early access is free.
What medical device service teams actually deal with
Why it stays broken
Field service software was built for copiers and HVAC, where a closed ticket is the end of the story. Across an installed base of 1,200 regulated devices a closed ticket is the start of a complaint decision, a trend review and possibly a reportable event.
A service report that never reached complaint handling is what a 483 observation looks like 14 months later.
This project consists of a standards-based schema and test tool developed by NIST researchers to assist medical device domain experts.
Neurobird Medical Device Field Service Dispatch Platform
Treat the service report as the regulated record it already is. Screen it against complaint criteria the moment the engineer writes it, with the device, the UDI and the tools already attached.
- 1Screen every service report against complaint criteria at the moment it is written, not at quarterly review
- 2Carry the UDI on the service record so field data joins to the device, the lot and the software version
- 3Keep calibration certificates for field test equipment attached to the visits that used it
- 4Track reportable event clocks from the date the engineer learned of the problem, not the date the office did
What changes with Neurobird Medical Device Field Service?
The same work, read left to right: how it runs today, and how it runs once the record is in one place.
| Today | With Neurobird Medical Device Field Service |
|---|---|
| The service report is complaint evidence, and most field software treats it as a closed work order | Screen every service report against complaint criteria at the moment it is written, not at quarterly review |
| Every device in the field has a UDI, a software version and a maintenance schedule, and the truth about which is where sits in 3 systems | Carry the UDI on the service record so field data joins to the device, the lot and the software version |
| An engineer signs off a repair without the calibration record attached, and an auditor finds it 8 months later | Keep calibration certificates for field test equipment attached to the visits that used it |
Who is this for?
Same visit, three different obligations.
You service what you make
Every visit is quality system evidence. You need complaint screening at close and reportability clocks that start from the engineer's date.
You service other people's devices
You carry obligations without owning the design history. You need clean, defensible records you can hand to the manufacturer and the hospital.
You maintain the fleet in house
You are managing 1,200 devices across departments. You need maintenance schedules, calibration evidence and a way to escalate what belongs to the manufacturer.
The installed base, visit by visit
A working preview. Tick a job to record it against the device.
Drag a job onto a engineer to assign it.
How does Neurobird Medical Device Field Service work?
The visit writes the record
Engineer notes, parts, software version and tools used are captured against the specific device and its UDI, on site, once.
Complaint screening happens now
Each report is checked against complaint and reportability criteria at close, so the 30 day and 10 working day clocks start from reality.
Evidence stays joined
Calibration certificates, previous visits and the installed base history stay attached, so an audit is a read rather than a reconstruction.
What actually governs a service visit
Useful if you are building a service organisation or preparing for an inspection. Each source links out.
21 CFR Part 820 became the Quality Management System Regulation on February 2, 2026, incorporating ISO 13485:2016 by reference. Servicing records are part of that quality system rather than outside it.
eCFR, 21 CFR Part 820Medical device reporting: a manufacturer files within 30 calendar days of learning of a device related death or serious injury, and within 5 work days when remedial action is needed to prevent a substantial public health risk.
eCFR, 21 CFR Part 803Reports of corrections and removals go in within 10 working days of the action being started. Field service is usually the mechanism by which a correction is actually carried out.
eCFR, 21 CFR Part 806Unique device identification requires a device identifier plus production identifiers, submitted to the GUDID. If your service records do not carry the UDI, field data does not join to anything upstream.
eCFR, 21 CFR Part 830ISO 13485 clause 7.6 requires monitoring and measuring equipment to be calibrated against standards traceable to national or international standards. In the United States that traceability chain ends at NIST.
NIST calibration servicesMedical device field service software questions, answered
Key terms
- What is medical device field service?
- Medical device field service is the regulated work of installing, maintaining, repairing, calibrating and updating devices at customer sites. It differs from ordinary field service because the service report is potential complaint evidence and the visit can trigger a reportable event, so the record has to survive an inspection years later.
Which regulations apply to servicing records?
21 CFR Part 820 became the Quality Management System Regulation on February 2, 2026, incorporating ISO 13485:2016 by reference. Part 803 covers medical device reporting, Part 806 covers corrections and removals, and Part 830 covers unique device identification. Servicing sits inside the quality system, not beside it.
How fast does a reportable event have to be filed?
Under 21 CFR Part 803 a manufacturer reports a device related death or serious injury within 30 calendar days of becoming aware of it, and within 5 work days when remedial action is needed to prevent a substantial risk to public health. Corrections and removals under Part 806 go in within 10 working days.
Why does calibration matter for field engineers?
Because the measurement is only as good as the tool. ISO 13485 clause 7.6 requires monitoring and measuring equipment to be calibrated against standards traceable to national or international standards, and in the United States that chain ends at NIST. A torque wrench in a van is in scope just as much as a bench instrument.
Does this replace our quality management system?
No. Document control, CAPA and design history stay where they are. This is the field layer: what the engineer did, on which device, with which tools, and whether it needs to become a complaint.
Why we are building this
Field service in a regulated industry is not ticketing. The engineer in the ward is generating the record that an inspector will read years later, and generic tools quietly encourage everyone to close it and move on.
Part 820 becoming the QMSR in February 2026 did not change that. It made it clearer: servicing is inside the quality system, and the field is where most of the evidence is made.
We would rather build this with service managers than with quality consultants. Tell us how your visits are recorded, and where we have got it wrong.
Where the requirement comes from
The federal rules a service record is judged against.
- 21 CFR Part 820, quality management system regulation The amended part that incorporates ISO 13485:2016, effective February 2, 2026, and covers servicing as part of the quality system.
- 21 CFR Part 803, medical device reporting Who reports what, and inside which deadlines, when a device is involved in a death, serious injury or malfunction.
- 21 CFR Part 806, corrections and removals Reporting requirements when a field correction or removal is undertaken, usually carried out by field service.
- 21 CFR Part 830, unique device identification Device identifier and production identifier requirements, and submission to the global UDI database.
How much does Neurobird Medical Device Field Service cost?
Priced per field engineer because the work is per pair of hands. Devices, sites and reports are unlimited on every tier.
- Installed base register
- Service reports with UDI
- Maintenance scheduling
- Calibration records
- Email support
- Everything in Small team
- Complaint screening at close
- Reportability clocks
- Trend review exports
- Named contact
- Everything in Service organisation
- Quality system handoffs
- Software version tracking
- Correction and removal support
- Onboarding included
Get free early access
If you run field service on regulated devices, tell us how a service report becomes a complaint today.
Straight answer on where this is: In development. Early access gets the working preview, influence on what ships first, and early access pricing. It does not get you a login today.
Prefer email? Write to office@neurobird.com and a person will reply. No autoresponder.