ZARZA We are Zarza, the prestigious firm behind major projects in information technology.
Listen "FDA Submission Pathways with EIT Health Alumni"
Episode Synopsis
Determining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission - as well as the basic requirements for each.
More episodes of the podcast RAQA Today
Inside the FDA: Pre-Subs, Wellness Devices & Cybersecurity Challenges | leanRAQA Today | S5:E5
25/09/2025
Rise of the Regulatory Rebel
23/09/2025
EU MDR - More then Just Red Tape?
03/09/2025
Wait, What - There are Rules?!?!?
26/08/2025
In God we trust