Industry · Medical Equipment
A device history record
that builds itself.
DynamxMFG records every operation with a time, a job, an operator and the lot or serial used. Medical equipment manufacturers get traceability, controlled routings and audit-ready production data without extra paperwork.
Sound familiar?
The paperwork behind every device
In medical equipment manufacturing the build is rarely the hard part. The hard part is proving, months later, exactly what went into a device and who checked it off.
Device history built by hand
Batch records get assembled after the event from travellers, sign-off sheets and memory. One missing signature can hold up release of an entire batch.
Lot and serial trails go cold
Components arrive in lots and leave as serialised devices. When the link between the two lives in a spreadsheet, a single field issue turns into weeks of guesswork.
Process changes are hard to control
A validated process only holds if the floor works to the current version. When instructions sit in folders and printouts, older revisions keep finding their way back to the bench.
Side by side
Spreadsheets and generic tools vs DynamxMFG
Generic tools cannot link a supplier lot to a serialised device, so the evidence an auditor asks for has to be rebuilt from paper.
| DynamxMFG | Spreadsheets and generic tools | |
|---|---|---|
| Lot and serial genealogy | Forward and backward traceability from a single search | Spreadsheet cross-referencing that takes weeks |
| Device history records | Production evidence complete the day the batch finishes | Assembled afterwards from travellers and sign-off sheets |
| Controlled change | Current routing and instructions carried to the operator | Printouts and older revisions back on the bench |
| Inspection and sign-off | Captured at the operation, held against the job | Paper forms signed later and filed separately |
| Audit readiness | Evidence on demand from live production data | A scramble through folders before every audit |
What you get
Everything a medical equipment manufacturer needs. Nothing it does not.
DynamxMFG is built around the process you already have, from goods in by lot through controlled assembly, inspection and serialised release.
Lot and Serial Traceability
Materials are received and issued by lot, and finished devices are recorded against their serial numbers. From a serial you can see every lot, operation and operator in that build. From a lot you can see every job and device it went into.
Replaces: Batch spreadsheets, stores ledgers, manual lot cross-references
Controlled Work Instructions
Routings, documents and data capture fields are released centrally and put in front of the operator at each operation. Your own change control decides when a revision is approved. DynamxMFG carries that approved revision to the floor and records which one was used.
Replaces: Printed work instructions, folder-based document control, bench copies
Quality Capture at the Operation
Inspection results, measurements and sign-offs are entered where the work happens, on touch screens or scanners at the bench. Fields can be made mandatory per operation, so a step cannot be closed until the required checks and readings have been recorded.
Replaces: Paper inspection forms, sign-off clipboards, retyped QC records
Evidence for Review and Release
Every operation is logged with a time, a job, an operator and the lots consumed. Batch review starts from a complete record rather than a hunt. Your quality system defines what a device history record must contain, and DynamxMFG supplies the production data behind it.
Replaces: Hand-built batch files, chased signatures, pre-audit folder hunts
Device history
The record you need for release, and for recall
Every operation carries a time stamp, the job, the operator and the materials consumed by lot. Because that is simply how the work is tracked, and not something added afterwards, the production evidence for a batch is complete on the day the batch finishes.
The same record works in reverse. If a supplier lot is questioned, you can find every job and every serialised device it touched, and see which of them have shipped. A recall conversation becomes a defined list rather than an open question.
- Lot to serial traceability in both directions
- Inspection and sign-off captured at the operation
- Current work instructions in front of the operator
The numbers
What manufacturers get from DynamxMFG
built-in reports, from live production data
from kick-off to running on the floor
more production capacity at GMC
on-time delivery at CPL
Rated 4.1/5 on Capterra, GetApp and Software Advice. Our ratings come from public review platforms, not testimonials we picked ourselves.
Getting started
Live in 90 days, not 18 months
We handle the implementation. Your team stays focused on production. Here is what your first 90 days look like.
Establish visibility and a trusted baseline
The first month replaces spreadsheet chaos and guesswork with a single source of live production data.
Regain control and remove obvious waste
With live data in place, your team shifts from reactive firefighting to data-driven action.
Prove the ROI and prepare to scale
The final phase turns your operational improvements into financial evidence.
Customers
What manufacturers say about DynamxMFG
“DynamxMFG is an excellent choice for manufacturers looking to digitise operations without being overwhelmed by complexity.”
“As GMC has grown, it had become harder for me to have such a keen view on components to see if those parts were profitable or not. DynamxMFG enabled us to monitor the machine time and see whether we are making a profit or a loss on each component.”
“The ability to dynamically modify BOMs after release, adding or removing items from work orders, scrapping and reworking parts, has been the single biggest improvement for our business.”
“We chose the system over competitors because of its ease of use, strong customer support and friendly delivery team. So far, everything has matched what was promised.”
“With DynamxMFG, all our production processes are tracked and the relevant data is captured. This increases our control over the business and helps us identify more opportunities to enhance efficiency and quality.”
“Our experience has been positive, and it was definitely worth switching. The support we have received has been extremely helpful. My favourite feature is the integration and automation capabilities.”
Questions
What medical equipment manufacturers ask us
Can DynamxMFG support our device history records?
It holds the production evidence they rest on. Every operation is logged with a time, a job, an operator and the lots consumed, and inspection data is captured at the point of work. Your quality system defines what a device history record must contain. DynamxMFG gives you the underlying production data, on demand and in one place.
How do you handle lot and serial traceability?
Materials are received and issued by lot, and finished devices are recorded against their serial numbers. From a serial you can see every lot, operation and operator involved in that build. From a lot you can see every job and device it went into, which is what you need the day a supplier raises an issue.
We work to validated processes. How are changes controlled?
Routings, work instructions and data capture fields are configured and released centrally, so the floor always works to the current version rather than a printout on a bench. Your own change control decides when a revision is approved. DynamxMFG carries that approved revision to the operator and records which one was used.
Does it suit cleanroom assembly?
Yes. Operators book on and off jobs from touch screens or scanners at the point of work, so there is no paperwork travelling in and out of a controlled area. Data capture fields can be made mandatory per operation, so a step cannot be closed until the required checks and readings have been entered.
How long until we are live?
Ninety days from kick-off. We configure routings, quality fields and work centres around the process you already have, so the system reflects your approved way of working rather than asking you to rework it around new software. Onboarding is done with your team, on your own products and orders.
See DynamxMFG running your production
Book a 15 minute walkthrough on your devices, your routings and your quality checks.
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