Navigating FDA and EU MDR/IVDR Compliance: Cybersecurity Strategies for Medical Devices

Join RunSafe Security and Critical Software for an essential discussion on the critical role of cybersecurity in protecting medical devices.

The growing connectivity of medical devices, such as MRI machines and infusion pumps, has significantly increased cybersecurity risks in healthcare. Modern equipment now features wireless connectivity and cloud-based storage, creating complex systems that are vulnerable to exploitation. Recent FDA reports highlight a rise in cybersecurity vulnerabilities, emphasizing the urgent need for robust security measures.

On November 7th at 10:00 AM ET, Doug Britton from RunSafe Security and Afonso Neto from Critical Software will address these challenges in a fireside chat. They will explore the shift from basic compliance to proactive security, focusing on FDA and EU MDR expectations for transparency and risk management. The discussion will cover practical strategies for enhancing device security without disrupting existing systems, drawing from real-world experiences to protect both legacy and new medical devices. Attendees will gain insights into balancing stringent security requirements with the practical needs of manufacturers and patients, ensuring that medical technologies remain secure and accessible.

Key Takeaways:

• Understanding FDA and EU MDR/IVDR cybersecurity requirements for medical devices
• Strategies for securing both new and legacy medical devices
• Balancing security implementation with device functionality and development processes
• Importance of transparency in device security capabilities and limitations
• Approaches to lifecycle management of medical device cybersecurity

Event Details:
Date: Thursday, November 7, 2024
Time: 10:00 AM ET