Nicholas Yap, MBE, is a driven professional specialized in artificial intelligence software as a medical device (SaMD), regulatory affairs, and quality assurance. Currently serving as the Regulatory Manager at Lunit International, they lead global regulatory compliance for AI-driven breast cancer screening solutions. Previously, Nicholas held key roles at Leica Biosystems and Fisher & Paykel Healthcare, contributing to quality and regulatory strategies in medical device commercialization. They also interned at Frost & Sullivan, engaging in market growth strategies. Nicholas holds a Master of Bioscience Enterprise and multiple degrees from the University of Auckland.
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