Session Speaker
Cybersecurity & Data Privacy in Medical Devices
Ensuring cybersecurity and data privacy is critical, especially as artificial intelligence (AI) becomes increasingly embedded in medical technologies. This session will examine the growing threat landscape for connected devices, recent FDA guidance on cybersecurity requirements, strategies to ensure compliance and product effectiveness, as well as risk management best practices for securing devices throughout their lifecycle.
William Hansen, Principal Consultant, Hansen Enterprises
William Hansen is an engineering and quality expert with nearly 30 years of experience in the aerospace, defense, and medical device industries. After earning his B.S. in Electrical Engineering from Wayne State University, he transitioned into the medical device sector, leading Design Quality Assurance teams and managing risk processes. In 2016, he developed innovative cybersecurity strategies to meet evolving regulatory demands. Today, through his consulting practice, William specializes in medical device risk management, cybersecurity, training, and team-building, helping organizations create secure, compliant, and effective products.