Joe Burke

Joe brings over 35 years of experience in the medical device industry, with a specialization in quality assurance and regulatory affairs, as well as additional expertise in operations and clinical management. He is highly proficient in developing and implementing Quality Management Systems compliant with U.S. regulations and international standards.
Joe excels in strategic regulatory planning for early-stage medical device companies, including proactive engagement with regulatory authorities to ensure the least burdensome pathways to market. He has a proven track record of coordinating third-party testing and conducting content reviews for regulatory submissions.