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Labeling including IFU – instructions for use
Supplying a medical device with the correct labeling is key to ensuring the intended use of the device and minimize risk. This requires a deep understanding of the needs of the user, of the device design itself and of the potential risks associated with the process of using the medical device. It also calls for clear and appropriate communication with the intended user.
Labeling includes the IFU (Instructions for Use), product labels and other forms of user communication. The process for creating the labeling for a medical device involves collaboration with risk management to establish e.g. the necessary descriptions, warnings, precautions and contraindications. Our Design Control team has extensive experience working with different stakeholders like e.g. product development and marketing for obtaining and prioritizing input for the development of appropriate labeling.
Moreover, we possess the regulatory insight needed for identifying the requirements for the IFU and can also assist with finding the correct UDI (Unique Device Identifier).