End-to-End Regulatory Support for Effective Regulatory Strategy and Timely 510(k) Submissions

A mid-size Medical Devices company, having an advanced class of wound dressing products, reached out to Freyr for strategy development and successful filing of 510(k) with the USFDA. While initiating the project, Freyr found technical challenges such as raw data has no FDA approved GRAS number, SOPs were not in line with 510(k) requirements etc.

Read this case to decode how Freyr provided timely Regulatory strategy for 100% quality compliance of technical documents required.