Everything you need
to know about Arianis

Unique Device Identification (UDI) is a regulatory identification system required by the European MDR 2017/745 for medical devices and by IVDR 2017/746 for in vitro diagnostic devices. It makes it possible to identify and trace each device throughout its life cycle, from manufacturing to clinical use. Arianis builds UDI management natively into its production and labeling processes.

Arianis structures production and traceability data (lot numbers, UDI, manufacturing history) so that it is easier to compile the records your regulatory obligations require, EUDAMED included.

Yes. Arianis is designed to support medical device manufacturers subject to ISO 13485, by providing lot traceability, non-conformity management and the retention of the production records the standard requires.

A Manufacturing Execution System (MES) is software that drives and tracks manufacturing operations in real time. Arianis is a lightweight MES specialized for medical device manufacturers, with the regulatory constraints specific to the sector built in (traceability, UDI labeling, lot management).

Yes. Arianis is sized for small and medium-sized manufacturers without significant IT resources, with a quick learning curve and a deployment that requires no heavy infrastructure.

Yes. Arianis can manage several workshops or production lines at the same time, with a consolidated view of manufacturing orders, stock levels and traceability steps.

Arianis tracks stock movements in real time, manages supplier lot numbers and raises reorder alerts. Each component is linked to the production history to ensure complete traceability, upstream and downstream.

Yes. Arianis handles inventory spread across several sites or warehouses, with a centralized view of levels and movements.

Yes. Arianis includes a UDI label module that generates the barcodes (GS1-128, DataMatrix, etc.) and the mandatory regulatory information directly from production data, with no manual re-entry.

Arianis supports the coding systems of the issuing entities designated by the European Commission (GS1, HIBCC, ICCBBA and IFA GmbH), whose choice determines the identifier syntax and the accepted carrier formats. Label templates can be customized for each product reference and target market.

Arianis links product reference and lot data directly to label printing, which greatly reduces the risk of errors due to manual entry. Consistency checks run before every print.

Arianis offers complete two-way traceability: from raw material to the delivered finished product (forward traceability), and from the delivered product back to the component lots used (backward traceability). This traceability is essential in the event of a lot recall or of an incident reported through device vigilance.

Yes. In the event of a quality alert or a recall, Arianis immediately identifies every finished product affected by a defective component lot, and reconstructs the full manufacturing history.

All production records, stock movements and data changes are time-stamped and archived in Arianis. In the event of an audit (notified body, national competent authority, customer), the data can be accessed and exported in a few clicks.

Deploying Arianis is fast compared with generic ERPs. A small or medium-sized manufacturer can be up and running within a few days or weeks, with dedicated support to configure product references and production flows.

Yes. Arianis offers connectors for integration with the main ERP systems, avoiding double entry between sales management and production management.

Yes. Arianis is available as SaaS, which spares manufacturers from investing in server infrastructure and ensures continuous regulatory updates.