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"
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 […]Continue reading "Emerging Best Practices for Successful Human Factors – Benchmark Report"
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. […]Continue reading "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"
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.Continue reading "Assessing Organization’s Human Factors Maturity (Capabilities) with the SHF 2.0 Framework"
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 […]Continue reading "Auditing a Human Factors Validation Project with the SHF 2.0 Framework"