John Beasley

John Beasley serves as Interim Vice President of Quality and Regulatory for ManaMed, LLC in his role as a retained consultant. He is also the founder and Senior Consultant of MedTech Review, LLC, a medical device regulatory and quality consulting firm established in 2003. John has 40 years of experience in medical device quality systems, regulatory submissions, FDA inspection response, ISO 13485, MDSAP, post-market reporting, and quality system remediation. His career includes leadership roles with Becton Dickinson, TÜV America, BSI, 3M Healthcare, and Mentor, as well as extensive consulting work with U.S. and international medical device manufacturers.

John has supported FDA 510(k) submissions, Warning Letter and FDA Form 483 remediation, internal and supplier audits, complaint and adverse event systems, and global regulatory strategy. He formerly held third-party Accredited Person status for the review of premarket notification submissions and currently holds RAC Emeritus status through the Regulatory Affairs Professionals Society. John has also published and spoken on medical device regulatory topics, including FDA 510(k) requirements, EU MDR and IVDR transition, ISO 13485, risk management, eMDR, global supply chain requirements, and medical device regulatory developments in Asia. He holds a Master of Science in Mathematics from Texas Tech University and a Bachelor of Science in Mathematics from Louisiana Tech University.