Should IT administrators be included as user roles in MDR technical documentation for SaMD?
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Linguistic validation is required when language could impact the device's safety or performance, especially if the device will be used in countries wi
I recommend reviewing the MDCG 2020-1 guidance for Software Medical Devices. Clinical evaluation for software according to this guidance is based on t
We were in a similar situation and the competent authorities defined our role as a distributor. If you are making the CE-marked software medical devic
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