Certificate No. 60130856

Certificate Number: 60130856
Certificate Holder: GENSPEED Biotech GmbH

Gewerbepark 2, Gebäude B
4261 Rainbach

Description see attachment
Design and development, manufacture and distribution of
detection of nosocomial infections, periodontitis and
molecular diagnostic test kits and instruments for the
Installation and service of instruments.

Fulfilled Standards: EN ISO 13485:2016
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.