ERP for medical device distributors.
Meet every distributor obligation under Article 14 of the Medical Devices Regulation with far less effort: UDI on every movement, conformity checked before every delivery, FSCAs narrowed down in minutes. Plus every figure of your business in real time.
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Every device traceable, by scan.
UDI-DI and UDI-PI are captured when you scan and linked to batch, expiry and serial number. No retyping.
No delivery without valid conformity.
CE marking, declaration of conformity and certificates are checked before every delivery.
FSCAs narrowed down in minutes.
When a field safety corrective action comes in, affected stock, batches and recipients are visible at once.
Less time hunting for evidence. More time for customers.
Goods receipt without gaps in the evidence.
UDI scan, conformity check and quarantine run right at goods receipt. Stock is released only once all evidence is in place.
Affected recipients found at once.
In a field safety corrective action (FSCA), entroit matches UDI, batch and shipping history. You see at once whom you need to inform.
Stored correctly, from class I to class III.
Storage conditions, temperature zones and sterility requirements per device class in one view. You see at a glance whether everything is in order.
No expired certificate goes unnoticed.
entroit warns you in good time before notified body certificates expire. If one lapses, the affected stock is blocked automatically.
One platform, from class I to class III.
Device classes, sites and product ranges run on one platform. New product group, new warehouse: the same processes apply straight away.
FAQ
Which obligations under MDR Article 14 does entroit cover?
The distributor obligations of Article 14 are built in: checking CE marking and declaration of conformity before every delivery, storage and transport conditions, cooperation on corrective actions and withdrawals, and the register of complaints and incidents with forwarding to the manufacturer, authorised representative and importer, and to the competent authority where required.
How is entroit prepared for EUDAMED?
entroit is designed around the current EUDAMED data model: UDI-DI and UDI-PI master data are maintained in the system and available as a structured data set for exchange, whether you act as distributor, importer or authorised representative.
How is UDI captured at goods receipt and dispatch?
By scan: the system recognises UDI-DI and UDI-PI and links them to batch, expiry date and serial number. Every movement (receipt, transfer, dispatch) is documented with the full UDI history.
How does entroit monitor notified body certificates?
Every notified body certificate is stored with the products it covers, its scope and its expiry date. The system warns you with configurable lead times and blocks the affected stock automatically on expiry. Every status change is in the audit trail.
Do we have to validate the software under the MDR?
The MDR itself does not require GAMP 5 validation. If your business is certified to ISO 13485, clause 4.1.6 applies: software used in QMS processes must be validated on a risk basis before use. entroit is built to be validated accordingly; the validation is the user's responsibility. We offer the documentation as an optional service.
We distribute class I to class III. Does that work in one system?
Yes. Device classes are kept apart, with their own processes per class for storage, sterility, temperature zones and retention periods. Several sites and product ranges run on the same platform.
Every batch traceable. From day one.
Thank you! We will send you your access within one business day.
See our privacy policy.