Lessons from the Frontline: Navigating Regulatory Challenges & Opportunities in Digital Health.

Carrie has almost 25 years of proficiency in regulatory, clinical, and market access strategies for US and global markets. Her expertise extends to commercializing medical products across all development phases, and she has held senior management roles such as Vice President and Director, overseeing global clinical research and regulatory teams. As a distinguished regulatory affairs leader, she has successfully brought medical devices to market by guiding them from viability through design, verification, and validation to global regulatory approvals.

Carrie has been instrumental in streamlining procedures, implementing best practices, and leading high-performing teams. Her extensive experience includes lecturing on regulatory aspects of the medical device product commercialization lifecycle, covering both US and international perspectives, including the FDA’s risk-based classification scheme, Software Validation and Verification, Premarket Notification (510(k)), Premarket Approval (PMA), and Investigational Device Exemption (IDE) submissions.

She is particularly adept at navigating the complex regulatory landscape for AI-driven healthcare solutions, ensuring compliance with US and EU software regulations, including those utilized by the FDA’s Digital Health Center of Excellence. Carrie's work in digital health and AI has significantly contributed to advancing innovative healthcare technologies that enhance patient outcomes and streamline clinical workflows