In this episode, Karandeep Singh Badwal and Duane Mancini discuss comparing regulatory at a startup vs. large organization, the growth of strategics regulatory department, software and AI as a medical device, how companies straddle the line of being a medical device vs. not, how various regulatory bodies are dealing with the rise in software as a medical device, why the FDA is doing such a great job in this space, a common error he sees with companies with software as a medical device, his background on how he launched his own regulatory practice, his favorite thing about being a consultant and so much more.
Karandeep Singh Badwal LinkedIn
QRA Medical LinkedIn
Duane Mancini LinkedIn
Project Medtech LinkedIn
Project Medtech Website