RAPS Workshop: Cybersecurity Unauthorized: The Latest in Medical Device Cybersecurity

Cybersecurity remains mission-critical for medical device manufacturers. As regulatory expectations, threats, and technologies continue to evolve, organizations must stay current with the latest approaches to securing devices and supporting regulatory submissions.

Securing medical devices and documents for regulatory submissions from cyberattacks is challenging. Many medical device companies struggle to retrofit their security programs to address hardening, vulnerability management, and global incident response. New statutory requirements in the United States are increasing the focus on planned postmarket activities in the submission process.

Health authorities spanning the US, European Union, Australia, Canada, and Japan have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes expectations for post-market expectations.

This timely interactive virtual 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 get a better understanding of how to translate regulatory expectations into concrete design and development. Organizational leaders will gain strategic knowledge that will increase the likelihood of gaining green lights from regulators while also teaching them how to establish trust with customers concerned about risk related to medical devices on their networks.

Learning Objectives

Upon completion of this two-day workshop, attendees will:

Thoroughly understand international regulatory expectations for medical device cybersecurity.
Know the main components of a product security program aligned with global expectations.
Understand how to use pre-submissions to reduce the likelihood of cybersecurity-related deficiencies.
Be able to build more successful cybersecurity content for regulatory submissions.
Learn key medical device security standards.

Who Should Attend?

Early and mid-stage career regulatory and quality professionals through the director level
Engineer-level to director-level R&D professionals

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Agenda

This event will be happening on 13 October and 15 October 2026 from 9-5 pm

An Introduction to Medical Device Cybersecurity Concepts and Challenges
Speaker: Michelle Jump

Medical Device Product Security Programs: Putting together the puzzle
Speaker: Michelle Jump

FDA’s 2023 Guidance and Policy Update
Speaker: Matthew Hazelett

FDA Select Update, 524B, and Omnibus
Speaker: Matthew Hazelett

eSTAR: Review of the Document Expectations
Speaker: Michelle Jump

Secure Design: You Can’t Mitigate Your Way to Security
Speaker: Matthew Hazelett

SBOM
Speaker: Michelle Jump

Security Risk Management and Threat Modeling
Speaker: Michelle Jump

Submission Strategies for Cybersecurity
Speaker: Matthew Hazelett

IEC 81001-5-1: Foundational Standard for Cybersecurity
Speaker: Michelle Jump

Labeling and Communication
Speaker: Michelle Jump

Overview of global regulatory expectations
Speaker: Michelle Jump

Postmarket Overview
Speaker: Michelle Jump

Threat Intelligence and Incident Response
Speaker: Michelle Jump

Vulnerability and Patch Management
Speaker: Michelle Jump

Disclosure and Advisory: When and How
Speaker: Michelle Jump

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.