Navigating Regulatory Challenges in the U.S. Healthcare Market

If you are building a MedTech startup and targeting the U.S. market, guessing your regulatory pathway is not a strategy. This session breaks down device classification and FDA pathways, along with how to communicate early with FDA to confirm strategy, de-risk development, and build investor confidence. We also cover emerging focus areas, including cybersecurity, AI/ML, human factors, and QMS expectations aligned with ISO 13485. Designed specifically for startups, this presentation provides the clarity you need to move from concept to commercialization with fewer surprises.

Steve Gompertz (CMQ/OE, CMDA, RAC-US, CMII) is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the medical technology industry providing guidance on quality systems and regulatory compliance.

Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program. He is a Distinguished Speaker with the Society for Quality Assurance (SQA) and was awarded the 2023 Charles W. Britzius Distinguished Engineer Award by the MN Federation of Engineering, Science, and Technology Societies (MFESTS).