Windi Hary
About Windi Hary
Windi Hary is a seasoned professional in regulatory affairs and quality management, with over two decades of experience specializing in software-as-a-medical device (SaMD) and AI-enabled digital health.
Windi Hary - Title and Role
Windi Hary holds the position of Senior Vice President of Regulatory Affairs and Quality Management. In this role, she oversees regulatory strategy and quality management for a variety of digital health products. Her extensive experience and expertise make her a key asset for navigating complex regulatory environments.
Windi Hary's Experience in Regulatory Affairs and Quality Management
With over two decades of experience in regulatory and quality management, Windi Hary has developed extensive expertise in ensuring compliance with global regulatory requirements. Her primary focus includes regulatory filings, design, and quality management for regions including the U.S., Canada, Japan, and the European Union. She specializes in software-as-a-medical device (SaMD) and AI-enabled digital health, bringing immense knowledge to these areas.
Windi Hary's Professional Background
Windi Hary spent more than 12 years at HeartFlow, where she last served as the Chief Regulatory and Quality Officer. Prior to that, she worked for eight years at Philips Healthcare, gaining valuable experience in the healthcare sector. Her background includes leading and consulting on various regulatory projects, making her an authority in her field.
Windi Hary's Consulting Expertise
Throughout her career, Windi Hary has consulted for numerous companies on a wide range of regulatory and quality management topics. Her consulting services include global regulatory strategies, regulatory submissions, quality system implementation, strategic planning, and human factors testing. This consulting expertise has helped numerous companies achieve regulatory compliance and enhance their quality management systems.