Certificate No. 60113364

Certificate Number: 60113364
Certificate Holder: BERMED Sp. z o.o.
Zaklad Produkcyjno-Handlowy
ul. Ozynowa 51
53-009 Wroclaw
Poland
Scope:

Design and development, manufacture, distribution
and servicing of medical gas pipeline installations
as well as distribution of related components,
surgical luminaires and luminaires for diagnosis

Fulfilled Standards: EN ISO 13485:2012
EN ISO 13485:2012/AC:2012
Certificate Type: QMS

Quality Management System
EN ISO13485 quality management standard for medical devices and related services

The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

The customer's quality management system is subject to regular monitoring.

Certified customers may use the test mark in their communication.

Further information on this service can be found here.