# 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.

- URL: https://neurobird.com/devicefield/
- Product: Neurobird Medical Device Field Service Dispatch Platform
- Niche: medical device field service
- Buyer: medical device service teams
- Status: in development, open for early access
- Updated: 2026-08-21

## What Neurobird Medical Device Field Service does

- 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
- Track reportable event clocks from the date the engineer learned of the problem, not the date the office did

## How it works

1. **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.
2. **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.
3. **Evidence stays joined** Calibration certificates, previous visits and the installed base history stay attached, so an audit is a read rather than a reconstruction.

## From the source material

> This project consists of a standards-based schema and test tool developed by NIST researchers to assist medical device domain experts.

Source: nist.gov, https://www.nist.gov/itl/health-it-testing-infrastructure/testing-tools/medical-device-communications-testing-project

## Industry context

- **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. (source: eCFR, 21 CFR Part 820, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/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. (source: eCFR, 21 CFR Part 803, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803)
- **806** Reports 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. (source: eCFR, 21 CFR Part 806, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-806)
- **830** Unique 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. (source: eCFR, 21 CFR Part 830, https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830)
- **7.6** ISO 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. (source: NIST calibration services, https://www.nist.gov/calibrations)

## Pricing

- Small team: $110 per engineer, per month
- Service organisation: $240 per engineer, per month
- Manufacturer: $420 per engineer, per month

## Questions

### 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.

## Sources

- [21 CFR Part 820, quality management system regulation](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820)
- [21 CFR Part 803, medical device reporting](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803)
- [21 CFR Part 806, corrections and removals](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-806)
- [21 CFR Part 830, unique device identification](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-830)

## Contact

- office@neurobird.com
- https://neurobird.com/