Rob MacCuspie, PhD, Manager of Regulatory Affairs at Proxima, what makes up a medical device, according to FDA classification standards. 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. Thanks for watching!