Introduction: Making Security Part of Your DNA

Think of secure development like building a car. You wouldn't wait until the car is built to add brakes - they're designed in from the beginning. The same principle applies to medical device security. Every line of code, every component choice, and every test you run either strengthens or weakens your device's security.

This chapter will guide you through:

• Writing code that resists attack (secure coding)
• Managing the security of components you didn't write (third-party software)
• Testing your device like an attacker would (security testing)
• Tracking what's in your device (SBOM management)

The goal isn't perfection - it's building devices that are resilient, maintainable, and secure enough to protect patients throughout the device's lifetime.

Sources

Primary documents for the topics in this section:

1. FDA premarket cybersecurity guidance, Section V.A.4 Third-Party Software Components and SBOM, FDA, February 3, 2026.
2. FDA premarket cybersecurity guidance, Section V.C Cybersecurity Testing, FDA, February 3, 2026.