Medical device cybersecurity is no longer just a technical exercise or a set of documents prepared before submission. Section 524B and FDA’s evolving expectations require manufacturers to demonstrate that cybersecurity is integrated throughout product development and the Total Product Life Cycle.
This session will translate those expectations into practical considerations for regulatory and engineering teams. We will explore what FDA expects in a premarket submission, the role of threat modeling, risk management, SBOMs, security testing, and vulnerability management in building the cybersecurity evidence package, and where manufacturers commonly encounter gaps.
Attendees will leave with a clearer understanding of what cybersecurity readiness looks like and how Regulatory Affairs and Engineering can work together to build a stronger, more defensible submission.
Location
NorthStar (Building 5 (CDMO facility)
1800 Gateway Blvd
Beloit, WI 53511
Cancellations and Refunds
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 [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speakers
