Certificado nº 60136137

Número de Certificado: 60136137
Certificado Titular: Abviris Deutschland GmbH

Beimoorkamp 6
22926 Ahrensburg
Alcance de la Certificación:

Design and Development, manufacturing and distribution
of in-vitro diagnostics in the context of HPV serology
(see attachment for additional sites included)
Site included:
Abviris Deutschland GmbH
37079 Göttingen
Robert-Bosch-Breite 23
Activities: : Design and Development

Estándares cumplidos: EN ISO 13485:2016
Tipo de Certificado: 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.