by Lisa Gallatin, RAC, Director of Regulatory and Quality | Feb 7, 2023 | ClinReg Strategy
Swift IDE approval is possible when your submission convinces FDA that you know your investigational device well and you have robust bench and pre-clinical data to demonstrate the device is ready for further evaluation in humans. This calls for clear technical, not...
by Lisa Gallatin, RAC, Director of Regulatory and Quality | May 11, 2021 | ClinReg Strategy
You are developing a medical device that addresses a clinical need, but how do you get it into the hands of physicians to improve the lives of patients? In this article, we discuss the most common FDA pathways to market clearance and share a few insights to help you...
by Lisa Gallatin, RAC, Director of Regulatory and Quality | Apr 6, 2021 | ClinReg Strategy
The voluntary FDA Q-Submission Program, specifically the pre-sub meeting process, can serve as a powerful tool to streamline and optimize your medical device product development strategies, timelines, and budget, especially if you need to conduct a clinical study. In...
by Lisa Gallatin, RAC, Director of Regulatory and Quality | Mar 25, 2021 | ClinReg Strategy
The medical device product development cycle can take several years and cost millions of dollars, especially when a clinical study is required. With an investment that large, it’s smart strategy to ensure your study design is locked-in well before you submit an...
