Rob MacCuspie, Manager of Regulatory Affairs at Proxima, is here to breakdown Pre-Submissions, which are useful tools emerging MedTech companies will want to consider when planning to submit a new device for FDA approval.
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.