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 industry.

Some of the highlights we covered during our episode together:

-Digital Health sector update

-Trials and Tribulations for getting Digital Health products approved and onto the market

-How he broke into Digital Health without previous experience and how you can too

...and so much more!