Redefining Human Factors Validations: Strategies to Increase Maturity for Successful Human Factors in Medical Devices and Combination Products

The integration of human factors (HF) engineering (or human-centered design) in the development of medical devices and combination products has become increasingly crucial for ensuring their safety, usability, and overall effectiveness. However, the implementation of HF practices has been accompanied by various challenges, hindering successful validation projects and regulatory compliance. It is clear that traditional approaches […]

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Emerging Best Practices for Successful Human Factors – Benchmark Report

Assessing and Advancing HFE Excellence This comprehensive industry benchmark report highlights the significant influence of the SHF 2.0 Framework on industry best practices. By exploring this report, stakeholders in medical device human factors gain unparalleled insights into their performance, enabling them to identify strengths and areas for improvement across the five core categories of best […]

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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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Assessing Organization’s Human Factors Maturity (Capabilities) with the SHF 2.0 Framework

SHF 2.0 maturity model provides a comprehensive framework for HFSPs to assess their maturity levels, understand the necessary steps for improvement, and establish best practices for successful HF validation projects.

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