Navigate regulatory nuances for your SaMD by following a structured approach to maintain compliance post-release.
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Shelly Holbrook
Director
Shelly has worked on complex human factors research problems for 10+ years in a variety of industries, with projects spanning the entire product lifecycle from inception to market. Her training in industrial and systems engineering has provided her the necessary skillset to evaluate both the human and technical components of systems to create intuitive, optimal solutions. Shelly has experience with both qualitative and quantitative research methods, specializing in formative and summative usability testing. Her work in community pharmacy health IT system development, in conjunction with electronic health record implementation, and device and software development in diabetes care has earned her multiple publications. Shelly has a MS and PhD in Industrial Engineering with a Human Factors research emphasis from Purdue University and a BS in Industrial Engineering from Clemson University.
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- Unlocking the power of user-centric design for business success
- Bold Insight to present on IFU design, digital telemetry, and other human factors topics at HFES Healthcare Symposium
- Improve medical device safety with these packaging design tips
- Bold Insight to present on global medical device testing, in-person research logistics during COVID at HFES Health Care Symposium
- Working from home: Tips for designing your workspace from an ergonomics expert
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