Do you feel confident you’ve correctly determined your medical device’s regulatory class? Have you identified the controls you’ll need to satisfy in order to meet FDA compliance?
If you’re unsure, don’t worry! Medical device classification can be a very nuanced process. FDA thankfully has resources in place for investigating existing device types, their classification, and associated controls. However, there are a number of factors that can influence your device’s classification you need to be aware of.
To help you build a bare-bones understanding of the device classification process and the factors that influence it, download our latest eBook: “Classify Your Medical Device for FDA Submission: A Practical Guide for Busy Medical Device Professionals.”
Download the eBook today to learn about:
As an all-in-one resource, the eBook will help walk you through the essentials of classifying your medical device and how to leverage existing FDA resources to help you maximize compliance.Do