Ashkon Rasooli

EnGenius Solutions

BIOGRAPHY

Ashkon Rasooli is the founder and CEO of EnGenius Solutions, a boutique consulting firm specializing in Quality Management Systems (QMS) for medical device software. With 14 years of experience, he is a recognized strategist in Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), having held key roles in product management, development, testing, and regulatory compliance at companies like Edwards Lifesciences, Alphabet’s Verily, and various VC-backed startups.

Ashkon remains at the forefront of AI-driven healthcare solutions, recently speaking on AI/ML at MD&M West 2025 and contributing to Good Machine Learning Practices with AFDO/RAPS. His expertise continues to shape the evolving landscape of medical device quality and compliance.