Nearly everything will change
Are you "MDR-ready"? We certainly are, and we will help you to make your medical devices MDR-compatible.
The transition period for the Medical Device Regulation (MDR 2017/745) ends on 25th May 2021, when the requirements for manufacturers who sell medical devices within the EU will change. The new directive aims to increase the levels of quality and traceability of medical products. It impacts the processes involved in manufacturing your products and will mean more testing and more documentation.
Adaptation of QM system and technical documentation
Manufacturers of medical devices must adapt their QM system to the new MDR and provide a considerable amount of new information.
Moreover, the requirements have increased regarding product documentation, which will become far more comprehensive and will also need to include documentation from the suppliers of components used.
This refers to all manufacturers who market medical products within the EU.
The MDR-compatible documentation must also include the user interface. The supplier must provide, amongst other things, product specifications, process information, risk analyses and certificates. This proves that the development, production and quality control of these components all meet the MDR requirements.
If you buy hand and/or foot controls from steute, we can optionally provide you with comprehensive product documentation which you can then include in your complete device documentation. This will make the approval process for your overall system – including the user interface – considerably simpler.
With steute Meditec you will be "MDR-ready" on time
With us as a partner by your side, you can present the manufacturing process of your user interface in a manner which is both clear and in accordance with the MDR. The approval for your overall system is then quicker and easier – and you are "MDR-ready" sooner.
We support your device approvals not only in Europe, but also for the US-American market. We at steute Meditec are FDA-registered within the FDA Establishment Registration (21 CFR 807) framework as a "Contract Manufacturer". We can therefore optionally provide you with FDA-compatible documentation and manufacturing of your user interface.
This has the following advantage for your device approval in the USA: we are already known to the FDA as a listed supplier and manufacturer. If you apply for approval for a medical system which is fitted with a steute Meditec user interface, we can optionally register as a "Contract Manufacturer" with the FDA Device Listing for your medical system. In this way we can work together to prove that your components and accessories are also manufactured at an FDA-registered production site.