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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Suzanne B. Schwartz, MD, MBA, Director, Office of Strategic Partnerships and Technology Innovation, Center for Devices
and Radiological Health (CDRH), FDA Suzanne B. Schwartz, MD, MBA is the Director of the Office of Strategic Partnerships and Technology Innovation (OST) at FDA’s Center for Devices & Radiological Health (CDRH). Suzanne’s work in medical device cybersecurity includes raising awareness, educating, outreach, partnering and coalition-building within the Healthcare and Public Health Sector (HPH) as well as fostering collaborations across other government agencies and the private sector. Suzanne has been recognized for Excellence in Innovation at FDA’s Women’s History Month for her work in Medical Device Cybersecurity.
Kevin Fu, Director of Medical Device Cybersecurity at the US Food and Drug Administration’ s (FDA) Center for Devices and Radiological Health, and Program Director for Cybersecurity in FDA’s Digital Health Center of ExcellenceKevin Fu is acting director of medical device cybersecurity at the US Food and Drug Administration’ s (FDA) Center for Devices and Radiological Health, and program director for cybersecurity in FDA’s Digital Health Center of Excellence. He is associate professor of EECS at the University of Michigan, where he founded the Archimedes Center for Healthcare and Device Security and directs the Security and Privacy Research Group. He is most known for the original 2008 cybersecurity research paper showing vulnerabilities in an implantable cardiac defibrillator. The prescient research led to more than a decade of revolutionary improvements among medical device manufacturers, global regulators, and international healthcare safety standards bodies, just as ransomware and other malicious software began to disrupt clinical workflow at hospitals worldwide.
Matthew Hazelett, Cybersecurity Policy Analyst, Food and Drug Administration Center for Devices and Radiological Health Office of Product Evaluation and Quality
Clinical and Scientific Policy Staff
Matthew Hazelett started at the US Food and Drug Administration (FDA) as a biomedical engineer within the Implantable Electrophysiology Devices Branch at the Center for Devices and Radiological Health (CDRH). His review areas include pacemakers, defibrillators, leads, and supporting devices, such as programmers and home monitors. Since starting at FDA, Hazelett developed a review focus in cybersecurity, participates in cybersecurity guidance development, and supports cybersecurity vulnerability assessments and reviews across CDRH. He became the cybersecurity policy analyst in FDA’s Office of Product Evaluation and Quality a year ago, focusing on cybersecurity policy development and implementation. Hazelett also has worked for a medical device research and development company as a test engineer and test manager overseeing device verification and validation testing.