Ellie Reynolds, Manager of Regulatory Affairs at Proxima Clinical Research, is here to help growing MedTech companies learn about the FDA's Breakthrough Device Designation, a program that aims to allow quicker access to devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
See if your device qualifies for BDD with this quick 2-minute quiz!
No matter where you're at in the process, there's a lot to plan to successfully get your device in the hands of end-users and to maintain regulatory compliance across global markets.
Proxima works with emerging biotech and medical device companies across all phases of development.
As a contract research organization, we organize our team in two distinct areas: early-stage advisory consulting and all-inclusive clinical trial services. The service you need. The speed you want. The attention you deserve.