Medical technology

Manufacturing software for medical technology

When every part has to be provable, it is decided on the shop floor: at the batch that gets carried along, and the inspection that gets documented.

In medical device manufacturing, traceability is not a convenience feature but a precondition for shipping. Yet in many plants it is still created on paper: batch numbers noted on travellers, inspection results filed in folders, and when a question comes in, the search begins.

Caesar carries batches and serial numbers along the operations and documents inspection steps where the inspection happens. The data is created within the workflow rather than afterwards, and it lands in SAP Business One through the official SAP Service Layer.

Where it breaks down in practice

Traceability on paper

Travellers and folders work as long as nobody asks. The moment an enquiry arrives, an answer turns into a research project spanning weeks.

Inspections live beside the order

When inspection steps live in a separate form, they eventually cannot be assigned to a lot unambiguously. That is exactly what surfaces in an audit.

Small lots, heavy documentation load

Typical for the industry: many variants, small quantities, full documentation effort per lot. The capture effort scales with it, the workforce does not.

Capture that takes too long

If documenting an operation costs a minute, it gets collected and done later. And therefore imprecisely.

What Caesar takes over on the shop floor

Capture while the work happens — not afterwards from memory.

Batches along the operations

Assignment happens during the operation, not afterwards. The path of a part through manufacturing stays reconstructable.

Serial numbers

Individual parts can be tracked one by one where a batch view is not sufficient.

Inspection steps in the workflow

Quality inspection is part of the order. Results are captured where the inspection happens and stay documented on the order.

Order tracking

Where a lot stands is visible without walking the hall — for production management and for answering customer calls.

Scrap kept separate

Good quantity and scrap are captured separately, so rates become visible per lot and operation instead of vanishing into a monthly average.

Everything in SAP Business One

Every posting runs through the SAP Service Layer into SAP B1. No second data store emerges that could contradict the first.

Why capturing at shop-floor pace is decisive

Documentation duties rarely fail on willingness but on capture time. If a confirmation costs three forms and a minute, it gets postponed, and what gets postponed gets reconstructed. Reconstructed data is exactly what raises questions in an audit.

That is why Caesar's interface is built for seconds and works with gloves on. This is not design cosmetics but the precondition for the data being created where it is supposed to be created.

What Caesar delivers — and what stays your decision

Caesar captures and documents: batches, serial numbers, inspection results, times and quantities, each on the order and the operation. This data is the basis on which traceability can be demonstrated.

What Caesar explicitly does not do: certify that this satisfies a particular standard or regulation. Whether your documentation meets the requirements of your quality management system is assessed by you and your notified body. We provide the tool and state openly where its limit lies.

From the cluster, for the cluster

Caesar-Solutions GmbH is based in Spaichingen, a few kilometres from Tuttlingen — the densest medical technology location in Europe. Caesar is developed in daily shift operation at Efinger-Instruments, our reference plant.

In practice that means: whoever calls us talks to people who know the same requirements and work in the same environment. A demo is a car ride away, not a video call with a head office in another time zone.

FAQ

Is Caesar MDR or ISO 13485 compliant?

That question cannot be answered for a piece of software on its own. Compliance concerns your quality management system as a whole, not a single tool within it. Caesar captures and documents batches, serial numbers and inspection results on the order. Whether your processes thereby meet the requirements is assessed by you together with your QM function and your notified body. We help clarify what data the system provides, but we make no compliance claim.

Can we run batches and serial numbers in parallel?

Yes. Where a batch view suffices, the batch is carried; where individual parts must be provable, the serial number. What that looks like for your articles we clarify on the concrete case.

We produce very small lots with many variants. Does that fit?

That is the norm in this industry and the reason capture time matters so much. Caesar is built so that a confirmation takes seconds, because otherwise the effort multiplies with every lot.

Do we need SAP Business One for this?

Currently yes. Caesar is built on SAP Business One and writes back through the official SAP Service Layer. If you run a different ERP, get in touch — we will tell you honestly whether and when that becomes an option for you.

How do we find out whether this works for us?

Best on one of your own lots. In a 30-minute demo we show the workflow live from the reference plant and walk through your specific case.

Show us a lot from your production

30 minutes, live from the reference plant, no slides. We walk through your process and say honestly where Caesar fits and where it does not.

Read on

Viele Wege führen nach Rom, aber nur einer in die digitale Fertigung.

Manufacturing software for medical technology · Traceability · Caesar Solutions