Original Insights: Success Factors of Human Factors Validation in Medical Device Development

Uncover the key success factors and best practices for optimized outcomes in your human factors validations. Contact us for personalized assistance and take a leap towards enhancing your HF strategy for unparalleled success in medical device development.

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Understanding the Key Success Factors in ‘Tools & Methodology’ within the Successful Human Factors 2.0 Framework (Part I)

Robust tools and methodologies are essential for achieving success in human factors (HF) validations for medical devices and combination products. Recognizing this importance, the Successful Human Factors (SHF 2.0) framework places great emphasis on “tools & methodology” as a fundamental pillar of best practices. By addressing the unique challenges of integrating human factors into product […]

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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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