Introduction

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are interested in entering the SaMD space, what do you need to know when it comes to FDA regulations and guidance?

In this episode of the Global Medical Device Podcast, Jon Speer talks to David Pudwill, “Mr. Regulatory”, who has nearly a decade of firsthand experience working for FDA.

Listen to Mr. Regulatory and Jon discuss all things related to SaMD from the perspective of FDA and how the agency is regulating these emerging medical device technologies.