Simon Yu

Senior Consultant @Devote Consulting

Develop and deliver organizational solutions and strategies for data governance, quality, management, and analytics to enable business and product innovation in the healthcare and life sciences sector. • Provide project and program management expertise for enterprise and organizational-scale IT solutions development and implementation (SaaS, PaaS, and IaaS) in the healthcare and life sciences sector for both GxP and non-GxP environments. • Lead client transformations in software development, verification, and validation for SaMDs, digital health technologies, and medical device software compliant with IEC 62304 and regulatory requirements set forth by the FDA and MDR.