Validating a Project Management Maturity Framework Based on the Emerging Best Practices for Successful Human Factors Projects that Require FDA Approval -Summary of Key Findings
Previously, this author pioneered exploratory research regarding the concerns, underlying variables, key success factors, and best practices pertaining to Human Factors (HF) projects for medical devices and combination products that seek Food and Drug Administration (FDA) approval. Because of this research, it was observed that the great majority of HF submissions to the FDA fail. […]
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