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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SHF 2.0 Framework – Use Cases

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 […]

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