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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Cybersecurity has proven to be a challenge not only with regard to ensuring the security of medical devices, but also
preparing documents for regulatory submissions. Health authorities in many regions, including the US, Australia,
Canada, and Japan, have released new cybersecurity guidance documents. In addition to premarket concerns, some of
these guidance documents also include expectations for postmarket expectations.
Medical device companies struggle to build security programs into quality systems that were likely not designed to
address typical security issues such as hardening, vulnerability management, and global incident response.
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their
organizations in the right direction when it comes to global cybersecurity expectations. Technical staff will benefit from
better understanding of how to translate regulatory expectations into concrete design and development activities.
Organizational leaders will gain strategic knowledge that will increase the likelihood of successful submissions and help
establish trust with customers who have concerns about risks related to medical devices on their networks.
22 December 2020 – 6 September 2021: Early Bird $800 Member | $900 Nonmember
7 September 2021 – 4 October 2021: Regular $900 Member | $1000 Nonmember
After this program, participants will be able to:
Who Should Attend?
This workshop will help regulatory and quality professionals develop the knowledge they need to help steer their organizations in the right direction when it comes to global cybersecurity expectations. Technical staff will benefit from better understanding of how to translate regulatory expectations into concrete design and development activities. Organizational leaders will gain strategic knowledge that will increase the likelihood of successful submissions and help establish trust with customers who have concerns about risks related to medical devices on their networks.
Michelle Jump is the Global Regulatory Advisor, Medical Device Cybersecurity at MedSec, where she is responsible for providing strategic leadership, training and advisory services to the medical device industry in the area of cybersecurity compliance, global regulations, standards, product security program development, and security risk management.
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 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 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.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
All cancellation requests must be submitted in writing to firstname.lastname@example.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance at the following the workshop.