Hayhurst Medical Technologies · Regulatory
Janet Kwiatkowski
Regulatory Advisor, MAE Group
Founder, president and CEO of MAE Group, HMT's regulatory advisor.
About Janet
Janet Kwiatkowski is the founder, president and CEO of MAE Group, a global medtech advisory and commercialization firm she established in 2013. With a background in mechanical engineering, regulatory affairs and executive leadership, Janet has led complex initiatives spanning global regulatory strategy, clinical affairs, quality systems, product development, engineering and operations, program governance, due diligence, commercialization, financial strategy and capital formation. She also serves as an expert witness in medtech matters.
Her experience extends across the medical device, in vitro diagnostic, SaMD, AI-enabled technology and regulated digital health sectors. She helps organizations align technical, clinical, regulatory and commercial priorities to move complex technologies from early assessment and evidence development through regulatory authorization, market entry and operational scale-up. Her prior experience includes leading global cross-functional teams across regulatory affairs, quality, engineering, operations, business development and product launches within medical device organizations.
About MAE Group
MAE Group serves as HMT's regulatory advisor. Founded in 2013, MAE Group is a global medtech advisory and commercialization firm supporting medical device, in vitro diagnostic, SaMD, AI-enabled technology and other regulated digital health companies.
MAE Group provides comprehensive U.S., EU and global regulatory services spanning product classification and pathway strategy, regulatory-agency engagement, premarket submissions, device registration, software and AI/ML strategy, and lifecycle compliance. Its additional capabilities include clinical affairs, quality systems, product development, program management, due diligence, commercialization, global trade compliance, financial strategy, investor readiness and capital formation.