29 min listen
Everything you Need to Know about SaMD from an FDA Perspective
FromGlobal Medical Device Podcast powered by Greenlight Guru
Everything you Need to Know about SaMD from an FDA Perspective
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
46 minutes
Released:
Mar 1, 2021
Format:
Podcast episode
Description
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.
Released:
Mar 1, 2021
Format:
Podcast episode
Titles in the series (100)
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson: Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical De... by Global Medical Device Podcast powered by Greenlight Guru