Navigate regulatory nuances for your SaMD by following a structured approach to maintain compliance post-release.
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Stephanie Wiltman
Senior UX Researcher
Stephanie has a unique interdisciplinary research background in biomechanics, behavioral psychology, and medical grade plastics. She also has variety of experience in imaging and spectroscopy devices. To each project Stephanie brings the integration of engineering and behavioral psychology to explore creative product insights and improve quality of life. She has published peer reviewed research and presented at national and international conferences. Stephanie has a PhD in Bioengineering from the University of Pittsburgh and a BS in Materials Science and Engineering and a BS in Psychology from Virginia Tech.
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- Bold Insight and Eli Lilly and Company co-publish journal article on novel assessment tool to enhance medical device usability
- Integrating AI with care: FDA reveals focus areas for forthcoming guidance on AI products
- Bold Insight to launch AI research project at the 2024 HFES Health Care Symposium
- Bold Insight to present on IFU design, digital telemetry, and other human factors topics at HFES Healthcare Symposium
- Bold Insight to present on global medical device testing, in-person research logistics during COVID at HFES Health Care Symposium
Read our team’s latest bold insights
AI Governance: Safeguarding innovation in an evolving regulatory landscape
Discover how leading experts at CES 2024 navigated the complex landscape of AI innovation and risk governance, offering invaluable insights into launching AI products responsibly amidst evolving regulations.
Decoding the user experience of conversational AI
Our CUI expert discusses the complexities of evaluating and improving UX in conversational AI, focusing on factors like personality, context, and conversation flow.
GenAI at the inflection point: Navigating the third wave
2024 is forecasted to be a crucial inflection point for AI, marking the third wave of transformative technologies. Here, we break down learnings on GenAI from our visit to the Consumer Electronics Show.