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The application and technology of medical devices varied 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 separate quality standards for their manufacturers.
In our particular case, this is the standard DIN EN ISO 13485.
Reliable mechanical and electrical safety and the usability of our products are essential for our customers and their users. This circumstance places particularly high demands not only on us as a manufacturer for medical equipment trolleys and support arms, as well as the participating suppliers and service providers. Also on the certification companies, which carry out the conformity assessment according to DIN EN ISO 13485.
Through the implementation of DIN EN ISO 13485, our products, services and processes continue to meet the essential safety and performance requirements of the guidelines and standards.
This is evidenced by external audits of the company mdc, medical device certification GmbH, with whom we have been working successfully for many years.
Through the regular certification, our customers can rely on us to implement customer requirements in accordance with legal requirements and in a manner that is consistent with standards. The carefully documentation, the required proof, the necessary risk assessment and product observation in the market before and after delivery and are provided by ITD on its own responsibility. Traceability allows us to trace our products and keep documentation long-term.