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The evaluation will consider the European Union's MDR Technical Documentation requirements and compare the purposes and device classification schemes ..
of the DHF, DMR, DHR, and TD. US companies must meet different design documentation requirements as they expand globally. The cGMPs require Design Control and the DHF, while the EU requires CE-marking documentation in the form of TD. Currently, the DHF and TD serve different purposes and goals, but the TD is becoming more similar to the DHF. Meanwhile, the DHF is incorporating some features of the TD while still serving distinct goals.
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