Considering the Dynamics of FDA Human Factors Validation Requirement: Implications of Failure and Need to Ensure Project Success - A Conceptual Framework KM Rojas, N Sharareh, L Cosler, D Santos 2019 International Symposium on Human Factors and Ergonomics in Health Care., 2019 | 10 | 2019 |
A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool KM Rojas, L Cosler, D Santos 2019 International Symposium on Human Factors and Ergonomics in Health Care., 2019 | 7 | 2019 |
Adverse events and over-the-counter (OTC) drugs: Is inappropriate labeling the problem?-The case of acetaminophen KM Rojas, H Li Proceedings of the Human Factors and Ergonomics Society Annual Meeting 61 (1 …, 2017 | 6 | 2017 |
Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings KM Rojas, L Cosler, D Santos Proceedings of the International Symposium on Human Factors and Ergonomics …, 2020 | 3 | 2020 |
Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview KM Rojas Proceedings of the International Symposium on Human Factors and Ergonomics …, 2020 | 2 | 2020 |
Project Management Practices and Key Factors for Success in FDA Human Factors Validations of Medical Devices and Combination Products KM Rojas State University of New York at Binghamton, 2020 | 1 | 2020 |
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 KM Rojas https://www.researchgate.net/publication …, 2023 | | 2023 |
Understanding FDA Human Factors Validation Projects–Preliminary Findings from a Survey KM Rojas, L Cosler, DL Santos IIE Annual Conference. Proceedings, 269-274, 2020 | | 2020 |