Medical device MES that builds the DHR while the device is being built.
V5 Ultimate runs device manufacturing on the floor — routed operations, enforced sequencing, component lot and serial capture, in-process inspection, non-conformance at the failing step — and assembles the electronic device history record from those signed steps. Nothing is retyped, nothing is reconstructed at release.
You're looking at a device MES because the DHR is assembled after the fact — and everybody knows it.
The DHR is a folder of travellers, labels and inspection sheets stapled together at release
Operators can complete operations out of sequence and nothing stops them
Component lots and serials live in three systems, none of which agree
Non-conformances get raised hours later, from memory, on a paper form
UDI and label data are re-keyed, so a label error is a recall risk
An FDA or notified-body audit means weeks of assembling evidence by hand
What a device MES has to do — configured before your kickoff call.
eDHR built from signed steps
Every routed operation, inspection, component lot, serial and signature writes straight into the device history record as it happens. Release reviews the live record, not a rebuild.
Routing and enforced sequencing
Operations run in the order the DMR says. Out-of-sequence, wrong revision, unqualified operator or out-of-calibration equipment is blocked, not warned about.
Component lot and serial genealogy
Every sub-assembly, component lot and serial binds to the finished device, so a field failure traces down to the supplier lot in minutes.
UDI, labelling and serialisation
GS1 UDI carriers, DI/PI construction and per-station ZPL label printing driven from the build record — no re-keying between systems.
Non-conformance at the point of failure
A failed in-process check opens the NC on the spot with the operation, lot, serial, operator and equipment already attached, and routes it to MRB.
ERP, PLM and CAD-adjacent integration
Work orders in from ERP, DMR revisions from document control, actual consumption and yield written back. Signed REST plus webhooks with idempotency keys.
What device manufacturers get out of it.
- DHR review at release drops from days of paper to hours of review-by-exception
- Out-of-sequence and wrong-component build errors are prevented, not detected
- Complaint and field-failure investigations start with the full build history already assembled
- Audit evidence for a given serial exports in one action
- First signed build on a line typically inside 30 days of kickoff
The regimes a device MES is measured against.
FDA QMSR (21 CFR 820, effective Feb 2026)
Harmonised with ISO 13485. Device records, production and process controls, acceptance activities and non-conforming product are modelled natively, not configured as generic forms.
21 CFR 820.184 — Device History Record
Dates of manufacture, quantity manufactured and released, acceptance records, labelling used and UDI — captured contemporaneously as the build runs.
ISO 13485:2016
Clause 7.5 production and service provision, identification and traceability, and control of monitoring equipment, all evidenced from live execution.
21 CFR Part 11 / EU Annex 11
Bound electronic signatures with structured meaning, hash-chained append-only audit trail, authority and operational checks.
EU MDR 2017/745
UDI assignment and Basic UDI-DI handling, technical-documentation evidence, and post-market traceability through to the distributed device.
Medical device MES, answered.
What is a medical device MES?
A manufacturing execution system configured for device production: it dispatches the work order, drives each routed operation on the operator's screen, enforces sequencing and revision control, captures component lots, serials and in-process inspections, and assembles the electronic device history record from those signed steps. A general-purpose MES executes; a device MES also produces a DHR that stands up under 21 CFR 820.184.
How is this different from your eDHR software page?
The eDHR page is about the record itself. This page is about the execution system that produces it — routing, sequencing, operator enforcement, inspection and equipment control. Most buyers need both, and in V5 they are one product, not two integrations.
Do we need a separate eQMS as well?
No. CAPA, document control, training, supplier quality, audits and change control run on the same data model as execution, so a non-conformance raised at an operation is the same record QA and the CAPA board work on.
Does it handle UDI and serialisation?
Yes — DI/PI construction, GS1 carriers, per-station label printing and serial-level genealogy through sub-assemblies to the finished device.
Will it satisfy QMSR when it takes effect?
V5 is already built against the harmonised ISO 13485 model the QMSR adopts, so device records, acceptance activities and non-conforming product handling do not need re-architecting.
How long is implementation?
Most device lines run their first fully signed build within 30 days. Multi-line or multi-site rollouts are typically 8–16 weeks depending on integration count.
Watch V5 build a device and its DHR at the same time.
Free trial. No sales gate. First signed build in 30 days.