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Al Crouse

VP, Quality Assurance & Regulatory Affairs at CVRx

Al is the Vice President of Regulatory Affairs and Quality Assurance at CVRx. He developed and implemented the quality system and was a key participant in all regulatory submission work at CVRx over the past 15+ years leading to European, FDA and Australian approvals for the quality system and devices. In addition, Al has participated in the MDIC and AdvaMed Case for Quality efforts for many years. Through this, CVRx has volunteered to pioneer new Case for Quality programs developed in conjunction with FDA to improve the quality of medical devices in general and the CVRx product line specifically, including pilots of FDA Critical to Quality assessments, maturity model assessments for the FDA Voluntary Improvement Program (VIP) and the Medical Device Information and Analysis Sharing (MDIAS) program of which he is an original Governing Committee member. Prior to CVRx, Al worked for Medtronic for more than 16 years in various divisions and management roles primarily in the areas of quality and reliability. Al has a Bachelor of Science degree in Electrical Engineering from Iowa State University and a Master of Business Administration degree from the University of Colorado.

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