Certificado nº 60140186

Número de Certificado: 60140186
Certificado Titular: livetec Ingenieurbüro GmbH

Marie-Curie-Str. 8
79539 Lörrach
Alemania
Alcance de la Certificación:

Design and development, production, distribution and
service of external cardiac pacemakers, therapeutic
lasers, ECG monitoring and recording devices and
high frequency catheter ablation therapy 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.