DHF / TF CREATION

Design History File / Technical File

Quality Engineers will help to create your device Design History File and/or Technical File to ensure compliant design control, risk management, design transfer, and manufacturing oversight.

PARTNER AND GROW WITH THE EXPERTS

We are a consulting firm dedicated to helping medical device companies develop and maintain effective and efficient quality systems. We provide specialized and custom consulting services for all classes of medical devices including Software as a Medical Device (SaMD).

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