[FEATURED] Premarket Innovators And SMEs (Part 2): Running Out Of Time In The EU MDR Race
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with […]
High-level Overview of the 4 510(k) Guidance Documents for Premarket Notification by the FDA that Benefit Both FDA Reviewers and Device Sponsors
Author: Suzanne Broussard, PhD The Premarket Notification 510(k) Program is the pathway used by manufacturers of low- to moderate-risk devices that are substantially equivalent (SE) to a device already on the market in order to begin the process of legally marketing in the United […]
