FDA Cyber Regulations Compliance
Cybersecurity for Medical Devices
Is your medical device FDA-compliant?
In today’s healthcare landscape, cybersecurity is more than a technical issue—it’s a matter of patient safety. As medical devices become smarter and more connected, they also become more exposed to cyber threats that can impact clinical workflows, data privacy, and human lives.
The U.S. Food and Drug Administration (FDA) now requires that cybersecurity be built into the design, development, and maintenance of any device that meets the definition of a cyber device.
At Orbik, we help medical device manufacturers secure their technologies and meet FDA cybersecurity expectations across both premarket submissions and postmarket obligations. With our platform myorbik, you can proactively manage risks, document compliance, and stay audit-ready—without slowing innovation.
What Is a Cyber Device?
According to the FDA, a cyber device is any medical device that:
- Includes software (firmware, OS, applications)
- Is capable of connecting to the internet, directly or indirectly
- Could be vulnerable to cybersecurity threats, such as malware, unauthorized access, or data manipulation
This includes:
- Software as a Medical Device (SaMD)
- Software in a Medical Device (SiMD)
- Connected hardware with embedded software
- Cloud-integrated diagnostic systems
- Mobile medical apps that exchange health data
If your product fits this profile, FDA cybersecurity compliance applies to you—regardless of device class or intended use.
What Are FDA Cybersecurity Regulations?
The FDA cybersecurity framework applies to medical devices that connect to networks, communicate with other devices, or store/transmit patient data. The regulations require:
- ✔ Secure-by-design development – Cybersecurity must be embedded throughout the product lifecycle.
- ✔ Risk-based security controls – Devices must be resilient against cyber threats.
- ✔ Software Bill of Materials (SBOM) – Transparency in third-party software components.
- ✔ Incident response and patch management – Manufacturers must ensure timely security updates.
- ✔ Pre-market & post-market compliance – Ongoing risk monitoring and regulatory reporting.
Failure to comply can result in regulatory delays, product recalls, liability risks, and reputational damage.
Threat & Risk Assessment
How Orbik Helps You Achieve FDA Cybersecurity Compliance
We take a proactive approach to medical device cybersecurity, ensuring that your products meet FDA regulations and are secure by design.
Identify vulnerabilities in medical device software, hardware, and networks.
Perform a gap analysis against FDA cybersecurity guidelines.
Develop a customized risk mitigation strategy to meet regulatory requirements.
Provide detailed documentation and reporting to support FDA submission and audits.
Secure Development & Testing
Secure Lifecycle
Implement secure software development lifecycle (SDL) for medical devices. Ensure security throughout every development phase.
Advanced Testing
Conduct penetration testing, threat modeling, and security validation. Identify vulnerabilities before deployment.
Data & Compliance
Ensure compliance with encryption, authentication, and data protection requirements. Make security a core feature of your medical devices.
We simplify the complex
Navigate FDA Cybersecurity Compliance with Confidence
Documentation & FDA Submission Support
- Generate and optimize Software Bill of Materials (SBOM) documentation.
- Assist with 510(k) premarket submission and postmarket cybersecurity compliance.
- Provide ongoing monitoring and FDA reporting assistance.
FDA cybersecurity compliance is essential for:
- Medical Device Manufacturers – Ensuring that devices are cyber-secure by design.
- Healthcare IoT & Software Providers – Protecting patient data and connected healthcare systems.
- Hospital & Healthcare Organizations – Securing networked medical equipment from cyber threats.
Future-Proof Your Medical Device Cybersecurity with Orbik
Cyber threats in healthcare are evolving, and FDA compliance is just the beginning. Medical device cybersecurity is an ongoing process—not just a one-time certification. At Orbik, we don’t just help you meet compliance standards; we ensure your cybersecurity strategy is future-proof, keeping your medical devices secure, market-ready, and resilient against emerging threats.
Let’s take your medical device cybersecurity to the next level.