Why Secure Boot Is Now an FDA Expectation

The FDA now expects medical devices to use a secure boot. Without it, devices can run unauthorized firmware, including malware or compromised code from supply chain attacks.

wolfBoot is a secure bootloader for embedded medical devices. It uses wolfCrypt to verify firmware signatures before allowing code to run. Only authenticated firmware executes.

For additional security:

• wolfTPM – Stores boot keys in hardware
• wolfHSM – Isolates cryptographic operations during boot

Secure boot helps manufacturers meet FDA requirements and prevent firmware attacks.

If you have questions about any of the above, please contact us at facts@wolfssl.com or call us at +1 425 245 8247.

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