Case Study 52: 510(k) Application for Artificial Intelligence based Software as Medical Device

Company Situation

The Client had developed a suite of innovative AI based software for multiple applications and had registered their products in EU, USA, and Japan and had planned to register its new Artificial Intelligence based software in USA. With limited regulatory expertise, Client wanted a global partner to ensure their product approval in markets of interest.

GRP Solution

GRP is a partner of choice for companies developing software as medical device (SoMD) and Artificial Intelligence based software as medical device for various applications. GRP has helped 20+ software obtain approval successfully with US FDA through 510(k) applications by assessing the predicate devices (if available), enabling testing, supporting with clinical studies to be conducted in USA, authoring and reviewing protocols and preparing 510(k) application based on comprehensive gap analysis to be submitted to FDA. GRP helped Client in preparing a roadmap for regulatory success and was able to obtain approval for client in timely manner.