Ellie Reynolds, Manager of Regulatory Affairs at Proxima Clinical Research, is here to help growing MedTech companies learn more about the FDA's Breakthrough Device Designation (BDD) program, specifically the timeline between initial BDD submission and approval. BDD 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!
Successfully getting your device approved and into the hands of end-users while maintaining regulatory compliance across global markets is a challenging process.
As a clinical research organization (CRO), Proxima organizes its team into two distinct areas: early-stage advisory consulting and all-inclusive clinical trial services. We are well-versed in regulatory compliance consulting with the FDA for emerging medical devices and products.
The service you need, the speed you want, and the attention you deserve, Proxima works with emerging biotech and medical device companies across all phases of development.