QM System

ISO 13485:2016

MDC certifies the complete fullfillement of the ISO standard

Since August 2019 our quality management system is certified according to the latest ISO standard for medical device development.
The mdc medical device certification GmbH confirms, that the QM-System from velixX corresponds to ISO 13485:2016 standard in all points.

ISO 13485 Certificate

Just in time before the 9th anniversary of the company’s foundation, the quality management system of velixX GmbH was certified according to ISO 13485:2016.

During the certification audit carried out on 22/23 July 2019, the velixX QM system was certified to meet all requirements of the standard. The audit report certified that all processes fully comply with the requirements of the standard without any deviation.

Based on this, the certification committee of mdc medical device certification GmbH issued the certificate to velixX GmbH.

velixX is very proud to be able to show that quality management does not depend on the size of the company and that the company has thus also been formally certified to work with medical technology-compliant processes.

The organization and management of modern development processes do not contradict good quality management.

For the customers of velixX, this is a further proof of the reliability and high result quality of the services offered.


Manfred Augstein
Wildbader Straße 7
68239 Mannheim
+49-621-437 08 001

Copyright 2018 © Velixx | Imprint | Privacy Policy | Deutsche Version
Cookie Consent with Real Cookie Banner