Many citations by the FDA include findings with respect to insufficient or lack of information in the Design History File. These findings include incomplete or absence of design verification and design validation documentation, discrepancies between the final design outputs and the Device Master Record (DMR), not following the procedures to make the device per the DMR, and incomplete or inaccurate production data of incoming, in-process and finished products. Learn how to eliminate these challenges and ensure compliance with FDA regulations, ISO quality standards and other global regulatory requirements.