Medical device vulnerability is a result of modern medical devices becoming more connected. They are connected to local databases, the cloud, and to patient’s smart phones. The need for effective cybersecurity to ensure safety has never been more critical, as cybersecurity incidents have rendered medical devices and hospital networks inoperable. Regulators are giving cybersecurity their highest scrutiny during submission review. Our solutions are NIST Cybersecurity Framework compliant, and our risk management documentation is AAMI TIR57 compliant.

Promenade Software Security Experts can help you with appropriate cybersecurity activities for your device. Using a risk-based approach, several options are often available to mitigate the determined risks, and your device-specific technologies will be used to determine the best fit for you. We will help you:

• Ensure best-in-class user and device authentication, content integrity, and confidentiality of data, ensuring defensible in-depth security.

• Perform a Risk Analysis, identifying and documenting the risks from your device’s potential threats and vulnerabilities.

• Generate the necessary submission documentation for the FDA, including Cybersecurity Design documentation and Risk Management documentation.

• Generate the documentation package per the EU MDR MDCG 2019 - 16 Guidance for Cybersecurity in Medical Devices, showing a Defense-in-Depth Design Strategy.

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