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[Podcast] Implementing Changes to SaMD under new EU MDR

September 6, 2019

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[Podcast] Implementing Changes to SaMD under new EU MDR

This podcast was hosted by Andrew Wu, the Software Consultant of Rook Quality Systems. You will find this podcast helpful for understanding changes imposed on SaMD under new EU MDR. SaMD manufacturer will find this podcast helpful for clarifications on qualification and classification changes on SaMD, and action items to demonstrate compliance toward new regulation. Link to the Podcast: https://www.greenlight.guru/blog/samd-changes-eu-mdr Issuance of clarifications for this podcast: 1. The broadened definition of medical device under MDR is to start include devices with prediction and prognosis functionalities. Please be aware that under MEDDEV 2.1/6, SaMD with prediction and prognosis funct

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