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HFE/UE Summary Report – What It is and How We Can Help Write It

HFE/UE Summary Report – What It is and How We Can Help Write It

By Patricia Anderson, MSE

Preparing proper documentation for an FDA submission can be a lengthy and daunting process. Luckily, when it comes to human factors specific documentation, Core can help you. An HFE/UE Summary Report is an important part of your FDA submission – it is the culmination of your research, design, and human factors (HF) process that defends your argument to FDA that your medical device or combination product is safe and usable.