The Successful Human Factors (SHF) 2.0 framework presents a unique and unified approach to elevate and benchmark Human Factors Engineering (HFE) in the MedTech sector. Specifically designed for medical device companies and HF organizations, this framework provides unprecedented transparency into HF performance and sets the stage for enhanced regulatory compliance.
Developed through groundbreaking research, SHF 2.0 transcends standard integration by offering a common structure and language for achieving excellence in HF. It empowers the assessment of maturity across five key categories of HF project success, each evaluated on a five-level scale: Planning & Documenting, Timing & Integration, People, Tools & Methodology, and Communicating & Reporting. Furthermore, it seamlessly aligns with Project Management Body of Knowledge (PMBOK) knowledge areas, identifying precise opportunities for refining project management processes.
By harnessing SHF 2.0, teams can effectively mitigate risks, reduce errors, and expedite project outcomes. The framework goes beyond regulatory requirements, it enables organizations to harmonize procedures, cultivate a culture of quality, and unlock the full potential of HF. Embrace the future of HF excellence with the proven, industry-focused SHF 2.0 framework.