Setting a regulatory strategy in the US market is a critical step in a medical device company’s journey. It requires understanding the general principles that govern the United States FDA’s thinking on risk and benefit for patients and demands the management team consider who, when and how to hire in the company’s early days. Participants will learn the key considerations to develop a winning regulatory strategy for digital health, medtech and diagnostics. Participants will also be provided resources to support a founder in developing and executing their strategy from concept through product launch. The presentation will also cover best practices for engaging the FDA to experience the most effective path to market.