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…

Max Kelsen

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