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Andrew has 10 years of experience in the medical device industry in various roles within quality assurance and regulatory affairs. During this time, he led preparation efforts for a successful first-time FDA inspection, research efforts to support 510(k) submissions, and investigation and resolution of product and process deficiencies. He also implemented statistical methods and lean tools to improve process efficiency. This experience has provided him with a unique perspective on how a quality system can be an effective tool for any company. At Bold Insight, Andrew is responsible for the development and maintenance of our quality system, ensuring the continuous improvement of our processes and the quality of service we provide our clients. Andrew holds an BS in Bioengineering from Michigan State University.
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Finding efficient ways to leverage post-market surveillance data to inform product development at an institutional level will be key for SaMD manufacturers seeking FDA precertification.
Healthcare symposium provides clarity for interpretation of FDA guidance documents related to human factors engineering.
I found myself discussing what can be done to increase the extent to which voice recognition systems are seen as a benefit rather than an annoyance with the research sponsors, and I said the same things as I said 10 years ago… improve the system to support and recognize more natural speech patterns.
One of the CES presentations I attended was a panel in the sports technology track called, The Future of Fan Engagement. The panel discussed cutting-edge research in the sports tech market and perspectives on the relationship between emergent media technologies and...