The application and technology of medical devices is much diversified and continues to evolve dynamically. Medical devices improve life quality and can save lives. The use and handling must be safe and reliable for users and the clinical staff. To ensure safety and performance, not only specific legislation has been established for medical devices, but also dedicated quality standards for medical device manufacturers. In our particular case, this is the standard DIN EN ISO 13485:2016.
Reliable mechanical and electrical safety and the usability of our products are essential for our customers and all product users. This circumstance places particularly high requirements not only on ITD as a manufacturer for medical equipment trolleys and support arms, but also to the participating suppliers and service providers. Additionally the certification companies, who monitor fulfillment of the requirements according to DIN EN ISO 13485:2016 need to go through accreditation.
Through the implementation of DIN EN ISO 13485:2016 processes are established, that ensure our products and services permanently meet the essential safety and performance requirements of the guidelines and standards. The company mdc, medical device certification GmbH, with whom we have been working successfully for many years, is confirming the performance of the ITD quality management system by regular audits.
Through the regular certification process, our customers can rely on us to implement customer requirements in accordance with legal requirements and in a manner that is consistent with regulations and standards. The carefully documentation, the required evidences, the necessary risk assessment and product market surveillance are well established processes at ITD.