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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 Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011.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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Considering the Dynamics of FDA Human Factors Validation Requirement: Implications of Failure and Need to Ensure Project Success– A Conceptual Framework

Posted on Past & Ongoing Researchby Dr. Katia Rojas

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 (FDA) now requires human factors (HF) validations before market approval. Manufacturers are responsible for ensuring their products are safe and effective through the application of HFE. However, key stakeholders are […]

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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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