Rob MacCuspie, PhD, Manager of Regulatory Affairs at Proxima, is here to help growing MedTech companies learn how the FDA classifies medical devices and what information they use to make this decision. Watch Rob review the three types of medical devices classifications and how the FDA views these classifications. Ensuring your medical device is classified properly allows you to move smoothly through the FDA approval process for a new medical device.
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.