Al Crouse
About Al Crouse
Professional Role: Vice President, Quality Assurance and Regulatory Affairs
Al Crouse serves as the Vice President of Quality Assurance and Regulatory Affairs. In this role, he has been instrumental in developing and implementing the comprehensive quality system at CVRx. His leadership extends to overseeing regulatory submission work, helping the company achieve significant milestones including European, FDA, and Australian approvals for their quality system and devices.
Educational Background: BS in Electrical Engineering and MBA
Al Crouse holds a Bachelor of Science degree in Electrical Engineering from Iowa State University. He further advanced his education with a Master of Business Administration degree from the University of Colorado. His strong educational background provides a solid foundation for his expertise in quality assurance and regulatory affairs.
Career Experience: Medtronic and CVRx
Al Crouse has extensive experience in the medical device industry, working at Medtronic for over 16 years. During his tenure, he assumed various management roles focusing on quality and reliability across different divisions. At CVRx, he continued his focus on quality, playing a key role in regulatory submission work and the development of the company’s quality system.
Regulatory and Quality Assurance Contributions
Al Crouse has been a key participant in regulatory submission work at CVRx, contributing to European, FDA, and Australian approvals. He has also been involved with initiatives like the MDIC and AdvaMed Case for Quality efforts, where he volunteered to pioneer new Case for Quality programs in collaboration with the FDA. Furthermore, Al is an original Governing Committee member of the Medical Device Information and Analysis Sharing (MDIAS) program.