A Brazil-based leading provider of Electrical Impedance Tomography System approached Freyr for necessary Regulatory support to update the CER for EU MDR compliance. The client was transitioning towards the CE certification under the new EU MDR 2017/745 and the Notified Body had raised few non-conformities during the conformity assessment. It was challenging to address the issued non-conformities, as they were new and not specific to the product in scope and required extensive data mining.
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