The SHF 2.0™ framework is designed to assess capabilities for successful human factors validation projects in the medical device industry, and can be used either at the organizational (processes) or project level (e.g. audit an HFE report). The SHF 2.0™ framework offers versatile applications and benefits multiple stakeholders, including internal or external human factors service providers (HFSPs) and […]
Continue reading "SHF 2.0 Framework – Use Cases"
The Food and Drug Administration (FDA) requires the application of human factors (HF) in the development of medical devices and combination products. The previous is checked through proper validation testing. The purpose of the HF validation is to demonstrate whether a device can be used by its intended users without any serious errors or hazards, […]
Continue reading "How Often, and Why, Will the FDA Reject your Medical Device Human Factors Submission?"
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.
Continue reading "Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings"
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 […]
Continue reading "Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview"
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 Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011.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 […]
Continue reading "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"
