A workshop scheduled for May 21–22 in Bethesda, Md, is intended to provide medical device manufacturers with industry best practices to achieve compliance and effectively assure medical device software safety.
Led by Fubin Wu, the cofounder of risk-management consultancy GessNet, the workshop faculty comprise CDRH staffers Paul Jones, Senior Systems/Software Engineer, Office of Science and Engineering Laboratories; Lisa Simone, Biomedical Engineer, Office of Science and Engineering Laboratories, Office of Biometrics and Surveillance; and Yi Zhang, Visiting Scientist, Office of Science and Engineering Laboratory.
Workshop attendees will be brought up to date on the FDA’s latest research on cybersecurity, medical device software best practices, software risk management related standards and guidances and key success factors for effective software risk management.
The workshop is hosted by FDANews. For more information on the event, visit the FDANews website.
