In Numbers:● 40: Largest SaMD Development Team Led● 12 : Years of SaMD/SiMD design and development experience● 9: Commercial FDA Regulated SaMD/SiMD Devices Worked On● 5: Publications and Presentations● 2: Policy-Making EngagementsAshkon is a medical device Quality Management Systems strategist with a focus on software as SaMD or SiMD. His unique background boasts first-hand experience in a variety of roles including product management, development, testing, QMS and regulatory and in a variety of business environments including established medical device companies with high-risk products such as Edwards LifeSciences, established tech companies with best-in-class software practices such as Alphabet's Verily, and a number of VC-backed startups at the forefront of such health tech sectors as digital therapeutics, wearables, and disease management platforms. He is a Summa Cum Laude graduate of University of California, Irvine with a Master of Science in Biomedical Engineering and a minor in management. His master's thesis involved development of signal processing algorithms for extra-cortical recordings based on which an academic paper has been published.With a keen interest in emerging SaMD/SiMD technologies and in particular AI, his latest activities in this area include a speakership on AI/ML applications at MD&M West 2024 and a podcast on applications of machine learning in medical devices. He is currently a member of the AFDO/RAPS Healthcare Collaborative working group on Good Machine Learning Practices (GMLP). In 2024, the working group is working on preparing a mock FDA submission for an AI-enabled device as a reference for the industry.