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Stil Orthosis: Odoo as the backbone for medical device production with strict component traceability

Stil Orthosis produces an anti-tremor orthosis — a medical device that significantly reduces trembling in neurological conditions. In medical device manufacturing, traceability is not a wish but a requirement. Odoo with the Quality Management module gives Stil the component tracking and quality assurance their sector demands.

Stil Orthosis B.V. develops and produces an anti-tremor orthosis: a smart device that significantly reduces trembling in neurological conditions such as essential tremor and Parkinson’s disease. The product helps people continue to perform everyday tasks — eating, writing, working — independently.

A medical device of this kind falls under European MDR regulation. That means every component must be traceable, every production step recorded, and quality assurance embedded in every process. This places specific demands on the ERP system.

The challenge

Stil Orthosis had grown to the point where operations could no longer be managed without a structured system. Separate spreadsheets for bills of materials, stock management via email and manual quality checks do not fit a company delivering medical devices. They needed a system that structures their production processes and provides the component traceability their sector requires.

The approach

We implemented Odoo with a focus on manufacturing, quality management and traceability.

Manufacturing and bills of materials

The Odoo Manufacturing module manages the bills of materials (BoM) for the orthoses. Every component — from the frame to electronic parts — is registered with lot and serial numbers. When a device is produced, Odoo records exactly which specific components were incorporated. That is the core of MDR traceability: in the event of a report or recall, you know precisely which devices contain which component batch.

Quality Management (QM)

The Quality Management module adds quality control checkpoints to the production flow. For each step in the production process, Stil can define which checks must be carried out. The results are recorded in Odoo — not in a separate system or spreadsheet, but directly linked to the production order. This makes quality reporting considerably simpler.

Inventory and shipping

The inventory administration tracks what is in stock, what is in production and what is going out. Lot and serial numbers are carried through all inventory movements. When shipping to end users or distributors, Odoo records the correct serial numbers per delivery.

Data import prepared by Stil themselves

A notable detail: Stil Orthosis prepared the data import files entirely on their own. This is by no means a given in ERP implementations — it requires an understanding of the data structure and discipline in preparation. The result was a smooth import and a faster go-live.

Result

Stil Orthosis now has a production management environment that meets the traceability requirements of the medical industry. Every device can be traced back to its components. Quality checks are an integral part of the workflow. And the operation runs on a system that grows with the business.


Further reading: Odoo for manufacturing · All client cases

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