Certificado nº 60145280

Número de Certificado: 60145280
Certificado Titular: MEDtech Ingenieur GmbH

Am Weichselgarten 7
91058 Erlangen
Alcance de la Certificación:

Design and Development of custumer specific electrical
medical devices and customer-specific softwar for
medical devices

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.