Critical Challenges in ML-Based SaMDs prompting FDA Action Plan

Max Kelsen
4 min readJan 27, 2021

Author: Navid Toosi Saidy, Quality and Technology Translation Lead at Max Kelsen

At Max Kelsen, we’re developing a range of advanced machine learning-based Digital Health solutions for a range of pressing issues across the healthcare and life sciences industry. We envision this next generation of software tools will be vital to improving healthcare…

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Max Kelsen

We are an Artificial Intelligence and Machine Learning consultancy that delivers competitive advantage for government and enterprise. https://maxkelsen.com