Successful Human Factors™ Unveils Services Addressing Project Delays and High FDA Failure Rates in MedTech
Notably, FDA data revealed alarmingly high failure rates in Human Factors (HF) submissions (as high as 96.1%). Leading the charge in optimizing HF projects in MedTech product development, Successful Human Factors™ unveils innovative, purpose-fit services. - October 25, 2023
The HFES Makes Hasty Maturity Model Policy Recommendations to the FDA: Insights from Successful Human Factors™ by Dr. Katia Rojas
In a recent development, the Human Factors and Ergonomics Society (HFES) has put forth policy recommendations regarding maturity models to the FDA. Dr. Katia M. Rojas, the visionary who initially proposed the idea of using a maturity model approach in the context of FDA HFE requirements back in 2019, shares her insights on this matter and scrutinizes its basis and implications. - September 25, 2023
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