Certificate No. 60108529

Certificate Number: 60108529
Certificate Holder: Fischer ANalysen
Instrumente GmbH
Brahestr. 25-27
04347 Leipzig
Germany
Scope:

Design and development, production, distribution,
installation and service of in vitro diagnostic medical
equipment and medical devices for respiratory gas analysis
devices and distribution of consumables

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.