MDR Technical file: all it's layers...
Regardless of a medical device class, or it's intended use, design, or even the safety history, the Technical File file is a live document of transparency and safety.
Read moreRegardless of a medical device class, or it's intended use, design, or even the safety history, the Technical File file is a live document of transparency and safety.
Read moreFDA latest guidance for 510 (k) regulatory submissions in an electronic format: eSTAR.
Read moreHow to improve your Clinical Evaluation Report (CER) for MDR compliance and Notified Body certification, here are some tips...
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