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Device Security 
We're helping protect facilities and patients from potential harm and minimizing risks.

DeviceSecure® Services & Solutions

Identify and resolve potential cyber security threats with Battelle DeviceSecure® Services & Solutions, a suite of cyber security services for medical devices. We combine expertise in cybersecurity, medical device design, hardware and software development, and user experience for a complete solution to medical device cyber security issues.

Advisory Services

Many medical devices today are connected to provider networks. And while that offers benefits to patients and healthcare providers, it also enables the possibility of cybersecurity attacks.

Organizational Cybersecurity Governance and Quality System Integration
Battelle can assist you in implementing an overarching medical device cybersecurity program to support total product lifecycle in accordance with current security guidance from various regulatory agencies.

Risk Management Framework (RMF) Compliance
Battelle can assist you in applying the RMF to your medical device design. By navigating the federal IT security requirements to identify what is required for your medical
device, Battelle can help develop a product design and documentation suite consistent with these requirements. If you would like to sell to the VA/DoD, then RMF compliance is mandatory.

FIPS 140-2 Compliance
Battelle can assist you in navigating the FIPS 140-2 requirements to identify what will be required for your product by government customers and in developing a cryptographic architecture consistent with government requirements. 

FDA Pre- and Post-Market Support 
Battelle can assist you at any stage of the product lifecycle to meet FDA pre- and post-market cybersecurity requirements.

 
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Vulnerability Assessment

Threat Assessment
The Food and Drug Administration (FDA) guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct 2018) requires medical device manufacturers to conduct a cybersecurity threat assessment and develop a cybersecurity plan to mitigate identified threats. The Battelle DeviceSecure team can help you meet FDA expectations and understand your cybersecurity risks.

Vulnerability Assessment and Penetration Testing
Characterize, assess, model, predict and measure the broad spectrum of threats and vulnerabilities posed by your medical device. An approved Mayo Clinic Security testing firm, we provide thorough security testing and analysis of hardware and software.

Vulnerability Mitigation and General Consulting
Got questions about whether a newly discovered security flaw concerns you? Battelle can help you assess and mitigate. We'll help you navigate the FDA pre-market and post-market cybersecurity landscape. 

DeviceSecure Services Development Process

Battelle's device security development process

Architecture Services

Secure Design and Usability
Minimize your risks and reduce the cost of security compliance by building cybersecurity into your device from the start. We offer a full spectrum of cybersecurity solutions backed by decades of cybersecurity experience for the Department of Defense and the intelligence community.

Secure Remote Software Updating Framework
With increasing emphasis from the FDA on ensuring that medical devices are patchable/updatable, it has become challenge for medical device manufacturer to incorporate software update mechanism in their devices without potentially increasing the attack surface. Battelle experts can help architecting and implementing secure software update mechanisms which mitigate threats arising due to increased attack surface due to connectivity. 

Automated Vulnerability Monitoring and Reporting
Automate the monitoring of newly discovered and reported security vulnerabilities in medical device hardware and associated software. 

Medical Device Cybersecurity Ecosystem
ecosystem of battelle's device security capabilities