Every device ships with a complete, signed Device History Record.
Built for 21 CFR 820 / QSR, ISO 13485, and the EU MDR.
← Different industryThe codes you're accountable to — at the data layer.
Five steps from receive to release — with the regulator on the hook at the end.
Tap to expand · download as PNG · paste into an audit prep deck.
From login to release — no end-of-shift paperwork.
- › part / lot
- › supplier
- › CoC
- › receive date
- › kit id
- › BOM rev
- › operator
- › time
- › serial
- › torque
- › operator
- › step time
- › test ID
- › result
- › inspector
- › deviation
- › cycle id
- › lot
- › dose / temp
- › release
- › UDI / GTIN
- › lot / serial
- › expiry
- › ship to
- Pre-shift·step 01DMR loaded
Production routing for the device family is the released DMR. Operators only see the current revision; obsolete revs are blocked.
21 CFR 820.181 - 07:30·step 02Kit issue
Components issued against the BoM with lot/serial captured. UDI block reserved for the unit at this moment.
21 CFR 830 - 08:30·step 03Sub-assembly
Operator scans into the bench. Step-by-step instructions enforce the order. Photo evidence captured at fastener torque steps.
- 10:30·step 04Final assembly
PCB + housing mate. Calibrated torque tools push readings live. A wrong tool = the step won't sign.
- 13:00·step 05In-process test
Functional test station writes pass/fail + raw waveform to the unit's eDHR. Failures route to rework, never silently scrap.
- 15:00·step 06Final inspection
QA verifies, e-signs, prints the UDI label at the workstation. DI + PI reconciled to the FDA GUDID record.
21 CFR 820.86 - 15:30·step 07eDHR closed
The complete record — components, operators, tools, tests, signatures — locks to that serial number. Pull it back in seconds for a complaint.
The terms your auditor uses
- DMR
- Device Master Record — the released specification for how a device is made (21 CFR 820.181).
- DHR / eDHR
- Device History Record — the per-unit record of how that specific device was made (820.184).
- UDI
- Unique Device Identifier — DI (model) + PI (serial/lot/expiry) printed on the device per 21 CFR 830.
- BoM
- Bill of Materials — the parts list and quantities for the assembly.
- CAPA
- Corrective And Preventive Action — the formal investigation + fix loop required by 820.100.
- Notified Body
- EU-recognised auditor that certifies your QMS for the MDR.
Sound familiar? We built this for you.
DHR reconstruction takes a paper-chase across binders, stickers, and shared drives.
Operator deviations are caught at final inspection — after rework cost is sunk.
Design changes don't propagate to the floor; obsolete revisions get built.
Notified Body audits surface gaps in training records and process validation.
The record assembles itself as the work happens.
No paperwork project at end of shift. No reconstruction at audit time. The evidence IS the workflow.
Self-building eDHR
Every serialized unit gets a signed, immutable record of materials, operators, equipment, and in-process checks — assembled in real time.
Hard-gated routings
Operators cannot advance to the next step until the prior step is signed, in-spec, and within design control limits.
UDI at point of build
DI + PI captured and printed at the workstation; reconciles to FDA GUDID.
Training enforcement
Operators are blocked from steps they aren't currently certified for. Training records ride with the DHR.
Spin up a workspace seeded for Medical Devices.
Default templates, validation rules, and report packs are pre-loaded for your industry. Run a real batch in under an hour.
Ask anything · No credit card · Onboard in days, not months