If you have anything to do with the Digital Health/SaMD sector of Med-Tech you'll probably recognize the name Vivek Thakkar. Vivek is a Regulatory Affairs expert, especially as it relates to SaMD (software as a medical device) products. He has spent the last 13+ years building a storied career across several Medical Device and Digital Health organizations the likes of Abbott Vascular, Cardinal Health, and Genentech/Roche to name a few.

Currently he serves as VP of Regulatory Affairs & Quality for Idoven. Idoven, has developed the world’s first cardiology-as-a-service platform powered by artificial intelligence that augments a clinician’s ability to identify, triage and diagnose patients at scale.

Simultaneously, Vivek, as Principal of RegSpace, LLC, provides Regulatory Affairs Consulting to numerous organizations across the indust ...