Certificate No. 60135483

Certificate Number: 60135483
Certificate Holder: GHC Global Health Care GmbH

Chariteplatz 1
10117 Berlin
Germany
Scope:

Design and development and integration of software
in medical devices for telemedicine
(see attachment for products and sites included)
Product included:
AescuLink Software
Site included:
GHC Global Health Care GmbH
Schmiedestraße 2b
15745 Wildau
Germany
Activities: Design, development and integration of
software in medical devices for telemedicine

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.