31 min listen
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA
FromGlobal Medical Device Podcast powered by Greenlight Guru
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
31 minutes
Released:
Dec 2, 2020
Format:
Podcast episode
Description
Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device industry. How are regulators keeping pace with its growth? FDA has a set of specific requirements unique to SaMD that companies are expected to meet in order to market these devices in the United States.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Andrew Frink, regulatory affairs manager at Proxima Clinical Research (CRO) about the ways in which SaMD companies can improve final submission outcomes of these devices by leveraging Pre-submissions to FDA, which involves meeting the agency's applicable regulatory guidelines and pre-sub expectations.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Andrew Frink, regulatory affairs manager at Proxima Clinical Research (CRO) about the ways in which SaMD companies can improve final submission outcomes of these devices by leveraging Pre-submissions to FDA, which involves meeting the agency's applicable regulatory guidelines and pre-sub expectations.
Released:
Dec 2, 2020
Format:
Podcast episode
Titles in the series (100)
What Device Makers Need to Know About Design Verification and Validation with Mike Drues: Here’s a question for our listeners: When it comes to making sure your medical devices are safe and effective, is it more important to find the right answers or to ask the right questions? In this episode of the Global Medical Device podcast, we are d... by Global Medical Device Podcast powered by Greenlight Guru