Quantifying Patient Capabilities and Setting the Stage for Future Development: Insights from a Sensor-Augmented Simulated Use Study with Pen Injectors
J Lange, AE Schneider, C Jordi - Medical Devices: Evidence and …, 2024 - Taylor & Francis
Background While formative and summative usability testing is essential to confirm safe and
effective product use, it may not be sufficient to comprehensively understand user …
effective product use, it may not be sufficient to comprehensively understand user …
Considering the Dynamics of FDA Human Factors ValidationRequirement: Implications of Failure and Need to Ensure ProjectSuccess-A Conceptual Framework
KM Rojas, N Sharareh, L Cosier… - Proceedings of the …, 2019 - journals.sagepub.com
Recognizing the role of human factors engineering (HFE) in the development of medical
devices and combination products that involve devices, the Food and Drug Administration …
devices and combination products that involve devices, the Food and Drug Administration …
Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects–Preliminary Findings
Since the FDA published guidance on the application of human factors engineering to
medical devices and combination products, the concerns about the quality and success of …
medical devices and combination products, the concerns about the quality and success of …
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 …, 2020 - journals.sagepub.com
This work is Phase II of a research theme on the topic of human factors validation projects for
medical devices and combination products. Initially, a review and analysis of the persisting …
medical devices and combination products. Initially, a review and analysis of the persisting …
Project Management Practices and Key Factors for Success in FDA Human Factors Validations of Medical Devices and Combination Products
KM Rojas - 2020 - search.proquest.com
Abstract In 2016, the Food and Drug Administration (FDA) issued final guidance entitled
“Applying Human Factors and Usability Engineering to Medical Devices”(FDA & CDRH …
“Applying Human Factors and Usability Engineering to Medical Devices”(FDA & CDRH …
Understanding FDA Human Factors Validation Projects–Preliminary Findings from a Survey
Since the FDA published guidance on the application of human factors engineering for
medical devices and combination products, the concerns about the quality and success of …
medical devices and combination products, the concerns about the quality and success of …
[引用][C] Validating a Project Management Maturity Tool Based on the Emerging Best Practices for Successful Medical Device Human Factors Projects that Require FDA …
KM Rojas