Rob MacCuspie, Manager of Regulatory Affairs at Proxima, is here to help growing MedTech companies learn about the three primary types of FDA pre-market submissions – 510(k), de novo and pre-market approval (PMA). For each submission type, learn what goes into each risk level and classifications. Ensuring your medical device is classified properly allows you to move smoothly through FDA’s market authorization that will impact the entire journey for your medical device to get to market.
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.