Successful auditing of the ITD processes DIN EN ISO 13485:2016

06/19/2019

Continuous improvement and optimization are the foundation for consistent quality. With extensive testing, we can ensure that our equipment carts and support arm of medical class I can be used safely every day without danger and meet the requirements for clinical use. 

Quality is a key issue on which we do not compromise. For this reason, we successfully passed the audit this year again to meet the legal and normative specifications of DIN EN ISO 13485:2016 for medical device. 

At the beginning of May this year, we set ourselves monitoring our processes. This re-certification took place at out office in Unterhaching and our two production sites in Johanniskirchen and Egglham. 

Random checks were made of the company compliance, internal and external processes, guidelines and much more. After three days of legislations, regulations and standards, the final results were clear: 

The quality management system of ITD GmbH shows standard compliant adequacy, suitability and effectivities. 

As a manufacturer of medical devices, we regularly undergo the audit of mdc, medical device certification. This enables us to continuously improve our processes and offer our customer even safer products.

You can download the new certificate DIN EN ISO 13485:2016 here