Medical Device
Cybersecurity Services
Fortify Your Medical Devices Against Evolving Cyber Threats
With deep expertise in medical device cybersecurity, we ensure strict adherence to regulatory requirements, and provide customized cybersecurity solutions that align with your device specifications and operational needs. With ICS by your side, you can safeguard patient data, uphold regulatory requirements, and maintain your reputation as a trusted healthtech innovator.
Secure Product Development Framework Services
Meet all quality system regulations and FDA expectations with ICS’ SPDF.
Software Bill of Materials Management and Reporting
Monitor and track your SBOM for known vulnerabilities, plus generate reports to ensure compliance.
Postmarket Monitoring and Long-Term Support
Let ICS handle complex and time-consuming Linux OS upkeep throughout your embedded device's entire lifecycle.
Industry-Leading Cybersecurity Solutions
In addition to medical device consulting services that span every phase of product development, from software strategy and design through postmarket support, ICS offers a range of cybersecurity consulting services – whether you’re looking for do-it-yourself options or want ICS to fully generate your submission – to help you prepare your premarket submission with confidence that it will not be delayed due to cybersecurity weaknesses.
Gap Analysis
Initial step to understand how much needs to be done and uses a broad range of standards and FDA Guidance documentation to ensure a comprehensive assessment.
Threat Modeling
Identify, assess and address potential security risks to protect your medical devices from unauthorized access, data theft and other threats.
Risk Evaluation
We use industry-leading methodology to prepare your full cybersecurity risk assessment, which is an integral part of an FDA 510(k).
Premarket Submission Services
We'll generate all cybersecurity documentation required for your FDA 510(k) or PMA submission.
Manufacturer's Disclosure Statement for Medical Device Security (MDS)
Provides invaluable information about your device’s capabilities and internal configuration, and plays a vital role in promoting device security and patient safety.
Static Analysis Compliance & Report
We’ll find and document defects in your codebase, such as programming errors and security vulnerabilities.
Penetration Testing
Identify vulnerabilities in your medical device software’s defenses before they can be exploited by hackers.
UL 2900 Assessment
Mitigate potential security vulnerabilities and exploits related to your connected medical device.
