Introduction: Security Doesn't End at Launch

Medical device cybersecurity continues for the entire life of the device. FDA expects manufacturers to monitor, assess, and respond to vulnerabilities for as long as a device is in clinical use, and under Section 524B those post-market duties are now written into law. Think of a new car: you wouldn't expect the manufacturer to stop caring about safety recalls after you drive off the lot. The same principle applies here, except your responsibilities actually intensify after market launch.

Why? Because:

• New vulnerabilities are discovered daily
• Attackers constantly develop new techniques
• Your device ecosystem changes over time
• Real-world use reveals unforeseen risks

This chapter will guide you through:

• Building an effective vulnerability monitoring system
• Managing coordinated vulnerability disclosure
• Responding to security incidents
• Communicating with customers and FDA
• Maintaining your security posture over time

The goal is creating a sustainable post-market security program that protects patients throughout your device's operational lifetime.