Those in the health sciences are uniquely involved in many aspects of medical device development, from the inception of the idea to its delivery in the marketplace. There is often a “black box” towards the end of this process where a device submission goes into the FDA and you hope an approval or clearance letter comes out the other side. Understanding the mechanisms of the FDA regulatory system governing the marketing and clinical use of medical devices in the United States can be enormously helpful not just at these later stages, but even during research and development of a new device! Being prepared regarding regulatory pathways and medical device classification will save huge amounts of time, money, and effort.
It is our goal to arm you with the FDA training you need to guide your device through the certification process and have a deep understanding of how the regulatory process is involved in every phase of medical device development.