For Software as a Medical Device (SaMD), FDA approval is not the end of cybersecurity responsibility—it is the beginning. Once deployed, SaMD products operate in real clinical environments, face evolving threats, and may remain in use for many years.
FDA increasingly expects manufacturers to demonstrate ongoing post-market cybersecurity management, including vulnerability monitoring, risk assessment, and coordinated response. Many SaMD teams underestimate these obligations, leading to compliance gaps and increased regulatory scrutiny.
This white paper explains how SaMD manufacturers can build a practical post-market cybersecurity program aligned with FDA expectations. It focuses on vulnerability management, patching strategies, and documentation practices that protect patient safety without disrupting clinical operations.
- FDA post-market cybersecurity expectations for SaMD
- Managing vulnerabilities across the device lifecycle
- Patch and update strategies that consider patient safety
- Coordinated vulnerability disclosure and communication
- Documentation regulators expect after approval
- SaMD product owners and engineering teams
- Cybersecurity and DevOps teams
- Quality and regulatory professionals
- Organizations preparing for FDA post-market inspections