Andrew Wu

Andrew Wu VP of Medical Software at Rook Quality Systems and Founder of Grasp Health, a BSI ISO 13485-certified organization with offices in Taipei and Carlsbad. He has nearly a decade of experience guiding medical device and Software as a Medical Device (SaMD) projects through technical development, quality, and regulatory strategy. His portfolio spans AI/ML-enabled diagnostics, digital therapeutics, wearables, and surgical planning software, with deep expertise in FDA software validation and IEC 62304 compliance.

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