My first SaMD FDA submission took me over a year with 3 FDA hold letters. 5 years and 10+ submission later, I can do them in 3 months or less. I made a lot of mistakes along the way. Help me help you avoid those. I have over 10 years of experience in the SaMD space as an engineer. I am a practicing AI/ML engineer and regulatory consultant with a clinical background so I can bridge knowledge gaps to help get AI/ML from concept to bedside. I enjoy working with people bringing AI/ML SaMD to market. Are you one of those people? I would love to hear your story!
