Global Medical Device Podcast: Why SaMD Companies Should be Leveraging Pre-Submissions to FDAView All articles
Catch Proxima's Regulatory Affairs Manager, Andrew Frink, on Greenlight Guru's podcast this week.
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 how companies can improve outcomes of bringing a SaMD to market by leveraging FDA's Pre-submission, which involves meeting the agency's applicable regulatory guidelines and pre-sub expectations.