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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.
17 January 2022 - 8 March 2022: Member $970.00 | Nonmember $1,150.00
After this program, participants will be able to:
Michelle Jump is the vice president of security services 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.
Cybersecurity Policy Analyst at FDA
Acting Director, Medical Device Cybersecurity at U.S. FDA Center for Devices and Radiological Health
Suzanne Schwartz, MD MBA
Director, Office of Strategic Partnerships & Technology Innovation, Center for Devices & Radiological Health, US FDA
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 following the workshop.