For manufacturers of medical devices, the steute business unit Meditec has an additional service to offer. Customers can not only benefit from high-quality user interfaces developed especially for medical equipment – from our standard range or customised, cabled or with wireless technology; they can also request that steute take care of the certification, validation and documentation of the control unit to all the relevant medical standards.
Guido Becker, Division Manager Meditec: "Our customers have the option of ordering MDR-compatible documentation, which they can then include in their overall device documentation with no extra effort. This allows medical device manufacturers to prove that production and testing of the user interface have taken place in accordance with the requirements of the medical directives."
From the point of view of the device manufacturer, this considerably reduces the effort of gaining approval for the overall system – which includes the user interface. And this new service is available not only for Europe, but also for the North American market. steute Meditec is registered with the FDA through the "FDA Establishment Registration" (21 CFR 807) procedure as a "contract manufacturer". This means that customers can optionally request FDA-compatible documentation for their user interface.
Guido Becker: "Creation of documentation – for the MDR and/or FDA – requires considerable effort. We have the necessary experience and are happy to support our customers with the required proof, taking some of the work off their shoulders and accelerating the approval process and thus the market launch of their medical device."
