Medical Device Manufacturing
Build the Device History Record out of the work order, not out of a binder assembled the week before the audit.
Medical device manufacturing software has to produce a record that outlives the device. A Device History Record has to show the dates of manufacture, the quantity made and the quantity released for distribution, acceptance records proving the unit was built to the Device Master Record, the labeling used on each production unit, and the device identification and control numbers that identify it. Then it has to hold up when an FDA investigator or a notified body auditor reads it years later. WorkCell builds that record out of the transactions that run the job. Versioned bills of material and routings carry the revision a lot was actually built to, operators record quantities, scrap, and inspection results at the operation, and component lots stay linked to the serial or finished lot they became. The same database schedules the floor against real capacity, so a quarantined resin lot reshuffles the plan instead of quietly missing a ship date.
Class I and Class II device makers, contract manufacturers building to a customer's Device Master Record, and the machining, molding, and assembly suppliers working under a device OEM's ISO 13485 flow-downs.
| Standard | What It Requires |
|---|---|
| ISO 13485 | Device quality management with explicit requirements for identification and traceability, production and process control records, and control of changes. FDA incorporated ISO 13485:2016 by reference into 21 CFR Part 820 as the Quality Management System Regulation, effective 2 February 2026, so the old QSR language now points at the standard's clauses. |
| 21 CFR Part 11 | Where an electronic record stands in for a paper one, it has to be attributable to a person, time-stamped, retrievable for the whole retention period, and protected so a change cannot go undetected. |
| ISO 9001 | The general quality management foundation ISO 13485 builds on: corrective action, internal audit, management review, and control of nonconforming product. |
| RoHS | Electrical and electronic devices placed on the EU market must stay under the restricted substance thresholds, which means holding a declared composition against every purchased component rather than chasing it per order. |
| REACH | Substances of very high concern present in a device, its accessories, or its packaging have to be declared, which requires supplier substance data stored against the part and carried into the assemblies that use it. |
Incoming material is received against a lot that carries its certificate and its inspection disposition, and a failed receipt stays on hold rather than being issuable by accident. Every issue to a work order preserves the link, and completions assign the serial or finished lot number that goes on the label. One device identifier resolves backward to each component lot, the operator who ran each operation, the acceptance results recorded against it, and the BOM and routing revision in effect that day. The question a field complaint raises, which parts share this lot and where did they ship, stops being a day of pulling travelers out of a filing cabinet. It also makes the usual argument moot: shops debate how far down the bill of material to trace because tracing costs labor, and when the transactions carry the genealogy themselves, tracing the whole structure costs nothing extra.
Dates of manufacture, quantity built and quantity released, acceptance records, the labeling and control numbers used, and the operator and inspection history, pulled from the work order rather than transcribed into a binder.
Incoming, in-process, and final inspection results recorded at the operation against the characteristic being checked, with the sampling plan that governed the decision attached.
Forward trace from a suspect component lot to every device it reached, and backward trace from a returned device to every lot inside it.
Severity-classified nonconformances with disposition and containment, escalated into an 8-D corrective action when the cause turns out to be systemic rather than local.
Generated from the work order, tying the shipped quantity to its lots, serials, and completed acceptance activities instead of being retyped per shipment.
The quantities are in the ERP, the inspection results are in a spreadsheet, the labeling proof is a PDF in a shared folder, and the operator sign-offs are on a paper traveler in a filing cabinet. Nobody has a DHR until somebody spends two days building one, and the build happens under audit pressure, which is the worst possible time to discover a gap.
The ERP knows what was consumed in aggregate, so the lot-level link gets maintained by hand in a parallel workbook that one person owns. It is accurate right up until that person is on vacation during a complaint investigation, and it has no way to prove it was accurate on the day the device shipped.
An eQMS holds the nonconformances and corrective actions, the ERP holds the work orders, and the link between them is a ticket number typed into a free-text field. Two subscriptions, two logins, two sets of part numbers, and a reconciliation meeting every month to find out which one is wrong.
Material under incoming inspection is marked with a tag on the pallet rather than a state in the system, so nothing stops an operator from issuing it to a job. The control exists in the procedure and in people's habits, and it fails on the day the floor is behind schedule.
A static spreadsheet schedule assumes the contract sterilizer turns the load around in a week and the bioburden result comes back clean. When either slips, the downstream operations were already promised to a customer, and nobody finds out until the ship date is gone.
The Device History Record falls out of the job
Quantities built and released, acceptance results, labeling and control numbers, operator and operation history, and the BOM and routing revision in effect are all written by running the work order. The DHR is a view over records that already exist rather than a document somebody has to compile.
Component lot to device serial genealogy
Receiving records the lot and its certificate, issues to a work order preserve the link, and completions assign serials or finished lot numbers. Forward and backward trace both resolve from one identifier, with no parallel log for anyone to maintain.
AQL acceptance activities and hold states
Sampling plans and inspection templates define what gets checked at receiving, in process, and at final. Material that fails sits in a hold state the system enforces, so a failed lot cannot be issued to a job because the floor was behind.
Nonconformance and 8-D corrective action in one loop
A failed inspection raises a severity-classified nonconformance against the job, the lot, and the part that produced it. Systemic causes escalate into an 8-D corrective action, and the whole chain stays attached to the record it came from rather than living in a second system.
Versioned BOMs and routings with effective dating
Every bill of material and routing carries a revision and an effective date, and changes supersede rather than overwrite. A lot built two years ago still shows the structure and process it was actually built to, which is what makes a historic DHR defensible.
Finite scheduling around sterilization and outside processing
The scheduler plans against real machine and labor capacity instead of pretending capacity is infinite, and proposal runs let a planner test a sequence before committing it. When a sterilization load slips, you see which shipments move before you promise anything.
Versioned BOMs and routings carrying the revision a device lot was actually built to.
InventoryLot and serial traceability from receiving to shipment, with enforced QC hold states.
QualityAQL acceptance activities, severity-classified nonconformances, and 8-D corrective action.
ProductionFinite capacity scheduling and operator terminals that capture results at the operation.
Quoting, engineering, inventory, scheduling, shop floor, and job costing on one database.
MESOperator terminals capturing actuals, acceptance results, and status at each operation.
QMSInspections, nonconformances, and 8-D corrective action tied to the lot that produced them.
APSFinite capacity scheduling around sterilization, test, and other outside processing.
What the standard requires and which records WorkCell keeps for it.
21 CFR Part 11What electronic records have to prove, and where the line between software and your validation sits.
Contract ManufacturersShops building to somebody else's Device Master Record and quality flow-downs.
PharmaceuticalComparable record-keeping depth under cGMP and batch record review.
What is medical device ERP software?
Medical device ERP software runs quoting, engineering, inventory, scheduling, production, and quality on one database, with the lot traceability and production records ISO 13485 and 21 CFR Part 820 require. The difference from general ERP is that the Device History Record and the part genealogy are first-class, not bolted on.
Can WorkCell produce an electronic Device History Record?
WorkCell keeps the records a DHR is made of: dates and quantities built and released, acceptance results at each operation, the operator who ran it, the control numbers assigned, and the BOM and routing revision in effect. It is a view over live records, not a separate document somebody compiles.
How far down the bill of material do I have to trace components?
Your risk analysis and device classification decide that, and the FDA's narrower traceability requirement applies to implanted and life-sustaining devices. Most shops trace critical components and skip hardware. WorkCell carries lot genealogy on every issue, so tracing the whole structure costs no extra labor.
Is WorkCell 21 CFR Part 11 compliant?
No vendor can hand you Part 11 compliance, because it covers your procedures and your validation as well as the software. WorkCell records who performed each transaction and when, keeps records retrievable, and enforces role-based access. Document control and approved electronic signatures are not features we claim today.
Does WorkCell handle UDI and GUDID submissions?
WorkCell holds the production identifier data a UDI carries: the lot or batch number, the serial number, and the manufacture date assigned at completion. Building the barcode symbology and submitting device identifier records to GUDID stay with your labeling and regulatory tooling.
Does WorkCell make us ISO 13485 certified, and what changed under the QMSR?
Certification is granted to your company by an accredited registrar, never to software. WorkCell supports the records the standard asks you to keep. Since 2 February 2026, 21 CFR Part 820 incorporates ISO 13485:2016 by reference, so the production and traceability records you keep for one now serve both.
See it run on your parts.
Tell us how your device records get built today and we will tell you straight whether WorkCell is a fit.