证书号 60130856

证书号码: 60130856
证书持有人: GENSPEED Biotech GmbH

Gewerbepark 2, Gebäude B
4261 Rainbach
奥地利
范围:

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

测试标准: EN ISO 13485:2016
证书类型: 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.