ISO 14971: Risk Management for Medical Device Cybersecurity

In 2025, the FDA reinforced the need to merge cybersecurity into existing safety processes by updating its Cybersecurity in Medical Devices guidance. Manufacturers are expected to integrate security into their quality system, premarket submissions, and postmarket activities — and ISO 14971 is the ideal structure to make this happen.

Why Cybersecurity Belongs in ISO 14971 Risk Management

Modern medical devices are more connected than ever — integrating with hospital networks, cloud platforms, mobile apps, and even patient-owned devices. This connectivity introduces a wider attack surface for malicious actors. A single unmitigated vulnerability could:

• Interrupt life-sustaining therapies or diagnostics
• Expose protected health information (PHI)
• Be exploited to alter device performance in dangerous ways

The FDA views cybersecurity risks as safety and effectiveness risks under the FD&C Act. This means your device’s security measures must be evaluated alongside clinical safety considerations, not as an afterthought. ISO 14971 provides the structure to ensure that security hazards are identified, controlled, and monitored using the same rigor as other safety risks.

📌 Pro Tip from Blue Goat Cyber

Integrating cybersecurity into ISO 14971 early in development is not just about compliance — it’s a competitive advantage that can streamline FDA reviews and build customer trust.

Step-by-Step: Applying ISO 14971 to Cybersecurity

The ISO 14971 process can be seamlessly adapted for cybersecurity risk management:

1. Hazard Identification

Document potential cybersecurity hazards that could impact safety, such as unauthorized access, malware injection, data tampering, or denial-of-service attacks. This step often benefits from formal threat modeling techniques.

2. Risk Analysis

Assess the likelihood and severity of each hazard. For cybersecurity, consider both the technical exploitability and the potential patient harm. For example, a vulnerability in a device’s wireless update mechanism could allow malicious firmware to be installed, leading to therapy disruption.

3. Risk Evaluation

Determine which risks exceed your acceptable thresholds and require mitigation. In cybersecurity, this often means addressing even low-likelihood risks if the potential patient harm is severe.

4. Risk Control

Implement technical, administrative, and procedural controls. Examples include:

• Strong authentication
• End-to-end encryption
• Network segmentation
• Secure software update processes

5. Residual Risk Assessment

Evaluate what risks remain after controls are applied and determine if they are acceptable. Any residual cybersecurity risk should be clearly documented in your device’s labeling in accordance with FDA cybersecurity labeling requirements.

6. Postmarket Surveillance

Continuously monitor for new threats and vulnerabilities. This includes vulnerability scanning, SBOM updates, and participating in coordinated vulnerability disclosure (CVD) programs.

Example: Applying ISO 14971 to a Wireless Infusion Pump

A manufacturer developing a wireless infusion pump identified a potential hazard: unauthorized wireless commands.

• Risk Analysis: Exploitability was medium; potential harm was high (incorrect dosage delivery).
• Risk Evaluation: Risk was deemed unacceptable without controls.
• Risk Control: Implemented WPA3 encryption, mutual device authentication, and an intrusion detection alert.
• Residual Risk: Minimal, but documented in labeling with operational recommendations for network isolation.
• Postmarket Monitoring: Ongoing penetration testing and SBOM vulnerability monitoring.

This approach not only addressed FDA requirements but also demonstrated to hospital procurement teams that the device met stringent security standards.

Best Practices for Cybersecurity in ISO 14971

• Integrate with SPDF: Align risk management with a Secure Product Development Framework so security is embedded in design.
• Use Threat Modeling: Identify attacker goals and pathways early.
• Maintain a Robust SBOM: Track all third-party components and their vulnerabilities.
• Engage Cross-Functional Teams: Cybersecurity risk management isn’t just for engineers — quality, clinical, and IT teams must contribute.

Common Pitfalls to Avoid

• Treating cybersecurity separately from safety risk management
• Failing to reassess risks after software updates or environmental changes
• Not disclosing known vulnerabilities in labeling
• Over-relying on IT security tools without clinical safety context

Partner with Blue Goat Cyber for Risk Management Excellence

At Blue Goat Cyber, we help medical device manufacturers implement ISO 14971-compliant cybersecurity risk management that satisfies FDA, EU MDR, and other global requirements. From threat modeling to SBOM development and postmarket monitoring, our experts ensure your devices are secure, compliant, and ready for market.

Don’t wait until a vulnerability becomes a recall. Contact us today to strengthen your risk management process and protect your devices and reputation.