Frequently asked questions
Regulations & Compliance
1. What is the UDI and why is it mandatory for medical device manufacturers?
The Unique Device Identifier (UDI) is a regulatory code required by European regulation MDR 2017/745 or MDR 2017/746. It enables each medical device to be identified and tracked throughout its lifecycle, from manufacturing to clinical use. Arianis natively integrates UDI management into its production and labeling processes.
2. How does Arianis help comply with EUDAMED requirements?
Arianis structures production and traceability data (batch numbers, UDIs, manufacturing histories) in a way that facilitates the compilation of records required under your regulatory obligations, including EUDAMED.
3. Is Arianis suited to the requirements of ISO 13485?
Yes. Arianis is designed to support medical device manufacturers subject to ISO 13485, ensuring batch traceability, non-conformance management, and the retention of production records required by the standard.
Production Management
1. What is a MES, and in what way is Arianis a MES suited to medical devices?
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, incorporating the regulatory constraints specific to the sector (traceability, UDI labeling, batch management).
2. Is Arianis suitable for small medical device manufacturers (micro and small businesses)?
Yes. Arianis is sized for small and medium-sized manufacturers who do not have significant IT resources, with quick onboarding and deployment requiring no heavy infrastructure.
3. Can multiple production lines be managed with Arianis?
Yes. Arianis enables the simultaneous management of multiple workshops or production lines, with a consolidated view of manufacturing runs, stock levels, and traceability steps.
Stock Management
1. How does Arianis manage raw material and component stock?
Arianis provides real-time tracking of stock movements, management of supplier batch numbers, and replenishment alerts. Each component is linked to the production history to guarantee complete upstream and downstream traceability.
2. Is multi-site stock management possible with Arianis?
Yes. Arianis supports the management of stock spread across multiple sites or warehouses, with a centralized view of levels and movements.
UDI Labeling
1. Does Arianis allow UDI labels to be printed directly from the software?
Yes. Arianis includes a UDI label editing module that generates barcodes (GS1-128, DataMatrix, etc.) and mandatory regulatory information directly from production data, with no manual re-entry.
2. What label formats does Arianis support?
Arianis supports the UDI standards (GS1, HIBCC, ICCBBA, IFA) defined within the European regulatory framework for the clear and formal identification of devices. Label templates are customizable according to product references and target markets.
3. How does Arianis help prevent labeling errors?
Arianis directly links product reference and batch data to label printing, eliminating the risks associated with manual entry. Consistency checks are built in upstream of each label print run.
Traceability
1. What depth of traceability does Arianis offer?
Arianis provides complete bidirectional traceability: from raw material to delivered finished product (downstream traceability), and from the delivered product back to the component batches used (upstream traceability). This traceability is essential in the event of a batch recall or an incident reported through materiovigilance.
2. Does Arianis support batch recall management?
Yes. In the event of a quality alert or recall, Arianis enables the immediate identification of all finished products affected by a defective component batch, and the full reconstruction of the manufacturing history.
3. How does Arianis facilitate regulatory audits?
All production records, stock movements, and data modifications are timestamped and archived in Arianis. In the event of an audit (notified body, national competent authority, customer), data is accessible and exportable in just a few clicks.
Deployment & Integration
1. How long does it take to deploy Arianis?
Arianis deployment is fast compared to generic ERPs. A small or medium-sized manufacturer can be up and running within days or weeks, with dedicated support for configuring references and production workflows.
2. Does Arianis integrate with an existing ERP?
Yes. Arianis provides connectors enabling integration with leading ERP systems, avoiding duplicate data entry between commercial management and production management.
3. Is Arianis available as a SaaS solution?
Yes. Arianis is available as a SaaS solution, eliminating the need for manufacturers to invest in server infrastructure and ensuring continuous regulatory updates.
🢂 Contact the Arianis team for a demonstration tailored to your activity.