Quality management has been an important focus for the Hemodia group since its creation. All of the group’s activities managed by the QMS have certification for ISO 13485;
Our ethylene oxide sterilisation unit (793 sterilisation cycles in 2014, that is 5826 pallets) is certified to ISO 11135-1 standard.
This means we can attach the CE mark to our products, a mark that guarantees compliance with European legislation for all devices.
The quality and safety of our supply chain is ensured by an ERP (Enterprise Resource Planning) system that connects all of our sites.
The notified body is LNE / G-MED.