Who are we
Salus Cons is a company registered for provision of the service of an authorized representative in the European Union to manufacturers established outside the Union. Salus Cons is registered in the EUDAMED database as an authorized representative under the single registration number (SRN) HU-AR-000006177.
Consulting services
In addition, Salus Cons is a company specializing in providing consulting services in the implementation of various management systems:
- ISO 9001 – General quality management system, applicable to all organizations
- ISO 13485 – Quality management system for medical devices, applicable to all organizations involved in the life cycle of medical devices (development, production of medical devices, production of raw materials for medical devices, packaging, labeling, storage, transport, and sale of medical devices)
- IEC / ISO 27001 – Information Security Management System.
Medical devices
Salus Cons provides consulting services for the preparation of complete technical documentation for medical and in vitro diagnostic devices, in accordance with the Medical devices regulation (EU) 2017/745 (MDR) and the In vitro diagnostic devices regulation (EU) 2017/746 (IVDR).
If necessary, we also provide support in the preparation of documentation and conducting clinical trials of medical devices.
As a confirmation of the quality of our services of an authorized representative and consulting services related to medical devices, Salus Cons is certified by the SIQ certification body according to the ISO 13485:2016 standard.
Consulting services
In addition, Salus Cons is a company specializing in providing consulting services in the implementation of various management systems:
- ISO 9001 – General quality management system, applicable to all organizations
- ISO 13485 – Quality management system for medical devices, applicable to all organizations involved in the life cycle of medical devices (development, production of medical devices, production of raw materials for medical devices, packaging, labeling, storage, transport, and sale of medical devices)
- IEC / ISO 27001 – Information Security Management System.
Medical devices
Salus Cons provides consulting services for the preparation of complete technical documentation for medical and in vitro diagnostic devices, in accordance with the Medical devices regulation (EU) 2017/745 (MDR) and the In vitro diagnostic devices regulation (EU) 2017/746 (IVDR).
If necessary, we also provide support in the preparation of documentation and conducting clinical trials of medical devices.
As a confirmation of the quality of our services of an authorized representative and consulting services related to medical devices, Salus Cons is certified by the SIQ certification body according to the ISO 13485:2016 standard.