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FDA Quality Systems Regulation Requirements - Regulatory Documents Explained

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GlobalCompliance Panel

GlobalCompliance Panel

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The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical.
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@lukehayden7861
@lukehayden7861 5 жыл бұрын
Fantastic overview! Very comprehensive and direct with helpful information for a beginner or expert in the industry.
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