Cybersecurity for Medical Devices —
from Regulation to Surveillance

Minneapolis, MN — September 26, 2023
San Diego, CA — September 28, 2023

Robust cybersecurity for medical devices is critical for ensuring patient safety and protecting sensitive healthcare data. Healthcare organizations across the world averaged 1,463 cyberattacks per week in 2022, up 74% compared with 2021.* The need to harden cybersecurity is at an all-time high. The FDA agrees. Recent (March 2023) regulations from the agency now require manufacturers to submit specific cybersecurity documentation with each 510(k) filing; without this, applications will be categorically rejected. The FDA also outlines the expectations for device manufacturers regarding cybersecurity throughout the product life cycle, including risk management, design controls and post-market surveillance.

This half-day session is designed to help you better understand and comply with this new guidance, and propel you on your medical device cybersecurity journey. We’ll explore key topics, from conception to implementation to surveillance. Industry experts will share their insights and engage in a panel discussion focused on best practices. 

The topics we’ll discuss include: 

• Evolving cybersecurity regulatory requirements from the FDA and EU
• Managing threat modeling, hazards and mitigations
• Creating a vulnerability management plan
• Designing a safe, secure and future-proof hardware and software platform
• Enabling interoperable and secure communications for real-time data flow
• Automating security implementation and penetration testing

We will also present solutions for designing real-time, multicore software architectures, establishing secure data connectivity, and leveraging best practices for protecting data and tools to enable supply chain security.

By attending this session, you will gain a deeper understanding of the current regulatory expectations surrounding cybersecurity in medical devices, and have the opportunity to ask leading experts your own questions on this timely topic.

Brought to you by RTI, ICS, QNX and BG Networks. 

The Minneapolis Forum will include a special guest presenter from NXP.

This in-person forum will take place in two locations: Minneapolis, MN and San Diego, CA. Attendance is free but seats are limited so please register today. 

8:30 - 9:00 a.m.      Continental breakfast
9:00 - 12:00 p.m.    Forum
12:00 - 1:30 p.m.    Networking lunch

*Check Point Research