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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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Given the multidisciplinary nature of MedTech and connected health, we have the opportunity to work with a wide variety of professionals including engineers of many stripes, scientists, researchers, designers, experts in regulatory, and quality management. Our...
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