Usability Testing

Usability Testing

Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings

Posted on Past & Ongoing Researchby Dr. Katia Rojas

The quality and success of human factors validation projects have put a strain on key stakeholders since the FDA published guidance. Learn about a new study on the characteristics, practices, and critical success factors in this field. Findings are presented to inform an industry-focused project management maturity assessment tool.

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Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview

Posted on Past & Ongoing Researchby Dr. Katia Rojas

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 concerns and also of the implications of failed FDA HF validation projects took place. One main problem delineated was that key stakeholders (namely procurers and […]

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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

Posted on Past & Ongoing Researchby Dr. Katia Rojas

As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly […]

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Auditing a Human Factors Validation Project with the SHF 2.0 Framework

Posted on HFE Strategy & Implementationby Staff

During this assessment, you will evaluate the maturity level of your finished (or in progress) medical device human factors projects using our Maturity Model (SHF 2.0), which is based on best practices for successful human factors projects, within the context of medical devices that seek FDA approval. The purpose of this assessment is to help […]

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