Certificate No. 60142068

Certificate Number: 60142068
Certificate Holder: GEOMED Medizin-Technik
GmbH & Co. KG
Ludwigstaler Str. 27
78532 Tuttlingen

Design and development, manufacture, distribution and
service of non active surgical and dental instruments and
arm systems for surgical procedures
(see attachment for additional sites included)
Site included:
PT GEOMED Indonesia
50118 Semarang, Indonesia
Industrial Park Terboyo, Block M62-64
manufacture and final inspection

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.