steute Technologies GmbH & Co. KG

Deutschland, Österreich

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Are you "MDR-ready"? - With steute Meditec you will be “MDR-ready” on time!

New Medical Device Regulation for medical devices: 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. 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. Find out more: www.mdr-ready.com

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