FREE ON-DEMAND WEBINAR
In recent years, FDA has rolled out two new programs that are designed to expedite the go-to-market process for innovative medical devices:
Both programs offer exciting opportunities for medical device companies, but the application processes for obtaining designation for each contain plenty of nuance.
Isabella Schmitt, Director of Regulatory Affairs at Proxima, is here to help webinar participants demystify BDD and STeP by explaining the application processes and why getting these designations early in the regulatory process can help clear your device’s pathway to approval.
Isabella will help you crack the code using the same methods used with successfully counseling multiple companies through BDD and STeP designation processes, and help you learn what it takes to achieve BDD or STeP designation for your medical device.