Al has over 20 years of experience in the medical device industry, including over 6 years in digital health, with a focus Quality, Regulatory and software design controls. He has worked with major medical device, pharmaceutical and diagnostic companies in establishing and re-engineering Quality Management Systems to establish FDA and ISO-compliant, best practices. Al has an extensive track record working with innovative companies with a variety of devices to achieve successful FDA 510(k) clearances and successfully prepare for and manage FDA and ISO audits. He has authored design control documentation for over 50 medical device product releases, over 25 510(k) submissions and CE Mark Technical Files.
Al has a Bachelor of Science degree in Management Information Systems from the University of Arizona and a Master of Science degree in Systems Management from the University of Southern California. His career has progressed from technical and management R&D positions with increasing responsibility, to a successful consulting career that has complemented that R&D background with extensive Quality and Regulatory compliance knowledge and experience.