RAPS Virtual Events Presents: Cybersecurity Unauthorized (Registration Fees Apply)

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. Cybersecurity has become mission-critical for medical device manufacturers.

Health authorities spanning the US, 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 interactive 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.

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.

Registration Fees & Deadlines

May 15, 2023 — October 14, 2023: Early Bird $825.00 Member | $970.00 Nonmember
October 15, 2023 — November 15, 2023: Regular $970.00 Member | $1,150.00 Nonmember

To Register: Cybersecurity Unauthorized (November 2023)| RAPS

Learning Objectives

After this program, participants 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 regulatory submissions

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.

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 gain 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 successful submissions and help establish trust with customers who have concerns about risks related to medical devices on their networks.