Quality and Environment

Protecting the environment, improving safe working conditions, and preventing pollution are consistently among LINET Group’s highest priorities and form an integral part of our responsible business approach.

Certified quality management system

The quality of products is ensured by an effective quality management system in accordance with EN ISO 13485 and complies with the technical regulations related to the product type.

LINET proudly holds QMS (Quality System Management) and EMS (Environmental Management System) certificates according to the international standards ISO13485, ISO14001, ISO9001, MDSAP and complies with the European Medical Device Regulation (MDR).
 
We operate under the environmental management system that complies with the internationally recognised ISO 14001 standards.

Medical device regulation

The MDR introduces new and stricter requirements for the placement of medical devices and their distribution within the EU with the main goal to improve clinical safety and traceability of all medical devices.
It also introduces the new central European Database on Medical Devices (EUDAMED), where all medical devices placed on the EU market will be registered, and much more.
 
In August 2021 we have already succesfully passed quality system audit according Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR).

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