Marc Lukacs, PhD Engineering Physics Queens University, is a product development specialist. He has worked on optical telecommunications, ultrasound imaging probes, ultrasound and optical imaging systems, wearables, and back pain therapeutics. As a Med Tech Director/Consultant, he is skilled in technology/product/process development requirements. This includes defining and aligning stakeholder and regulatory needs and strategies while realizing medical devices that contain hardware, firmware, and associated SiMD and SaMD software. Marc enjoys working on leading edge concepts and was fortunate enough to commercialize his PhD work; a platform of high frequency linear arrays for Visualsonics.
He is familiar with the process of transferring ideas from research to industry and can work with people on both sides of that relationship. He has a proven track record of building lasting relationships with suppliers. He is well-versed in QMS and QSR requirements and achieved ISO 13485 certification for Conavi Medical. He understands how to build appropriate objective evidence to support the requirements of design control, ISO 14971 risk management, verification and validation testing and product transfer to manufacturing.