Marc Lukacs

Marc Lukacs, PhD (Engineering Physics, Queen’s University), has 25+ years experience working at the intersection of business needs with product development, regulatory strategy, and quality compliance. His work spans optical telecommunications, ultrasound and optical imaging/tracking systems, back pain therapeutics, e-textiles and wearables, and software products.

He has successfully translated early-stage research into market-ready devices and is skilled in guiding complex products that integrate hardware, firmware, and both SiMD and SaMD software. He has led organizations through ISO 13485 certification, design controls, ISO 14971 risk management, verification and validation, and technology transfer to manufacturing. His expertise extends to emerging areas such as digital health, cybersecurity, and AI/ML-enabled devices and supports organizations through regulatory pathways including Q-Submissions, Predetermined Change Control Plans, Cybersecurity Secure Product Development Frameworks, and eSTAR premarket submissions.

As a mentor, he brings leadership, collaboration, and practical problem-solving to the forefront, equipping emerging health innovators with the strategies and tools to bring transformative technologies to patients.