Make a Cybersecurity Testing and Postmarket Surveillance Plan for Your Medical Device

It’s more important than ever to take cybersecurity requirements into account during and after medical device development.

Arunkumar Prabhakaran, Regulatory Associate III

Matt Hogan, Twin Tech Labs

The Importance of Cybersecurity Vulnerability Testing for Medical Devices

The increasing reliance on digital technology in the health care industry has led to significant advancements in medical devices and software components. However, this digital transformation has also introduced new cybersecurity risks, making vulnerability testing a critical aspect of ensuring the safety and integrity of these devices. Cybersecurity threats to modern medical devices can occur almost anywhere in the development cycle: device development, clinical trial records, submission development, and postmarket surveillance.

This article delves into the importance of cybersecurity vulnerability testing for medical devices, including software components that interface with them. It covers the methodologies employed, the outcomes of such testing in terms of risk management and mitigation, and specific details on penetration testing using Burp Suite, as well as vulnerability scanning and code scanning.


Cybersecurity Requirements

Medical devices containing software (also known as cyber devices) present a growing target for threat actors seeking to gain access to private medical health information and disrupt the health care industry. Keeping cyber devices safe after they enter the market can pose particular problems since new vulnerabilities come to light every day. With the potential risks of cybersecurity attacks on medical devices more pronounced than ever, FDA has expanded its effort to educate the medical device industry about these risks and the need for reliable risk management plans.

As part of its cybersecurity initiative, FDA has already issued guidance documents, fact sheets, and threat modeling playbooks. Recently, FDA added Section 524B “Ensuring Cybersecurity of Devices” to the FD&C Act and released a guidance document providing recommendations to ensure that the cyber devices undergo appropriate postmarket surveillance.

Per this new policy, manufacturers should submit a plan to monitor and address postmarket cybersecurity vulnerabilities in your premarket submissions (such as 510(k) and De Novo) along with other cybersecurity and software documentation. As of October 1, 2023, all submissions for cyber devices without a postmarket risk management plan will not pass an initial RTA check, so a reliable postmarket surveillance plan is more important than ever.


Medical device manufacturers can identify cybersecurity vulnerabilities and create a plan to mitigate related risks using a variety of approaches. The common one is to perform Vulnerability Testing and Penetration Testing along with conducting risk analysis. Identifying these security issues allows manufacturers to address potential cybersecurity risks and ensure that their postmarket cybersecurity plan leads to effective risk mitigation.

Some of the Benefits of Cybersecurity Testing

Mitigating Cyber Threats

As medical devices become more interconnected and rely on software components for their functionality, they become vulnerable to cyber threats. These range from data breaches and patient privacy violations to potential disruptions in health-care services. Cybersecurity vulnerability testing allows manufacturers and health-care institutions to identify and address potential weaknesses before malicious actors exploit them. Deeply understanding the threats and weaknesses allows you to implement effective risk mitigation strategies, ultimately safeguarding patients and health-care data.

Ensuring Patient Safety

The safety and well-being of patients are paramount in the health-care sector. Medical devices, especially those connected to the internet, can be vulnerable to cyberattacks that compromise their functionality or tamper with patient data. Vulnerability testing helps ensure these devices are resilient against potential cyber threats, which minimizes the risk of harm to patients and preserves trust in the health-care system.

Approaches to Cybersecurity Testing

Penetration Testing Using Burp Suite

Penetration testing is a proactive cybersecurity approach that simulates real-world attacks on medical devices and their software components. One popular tool for conducting penetration tests is Burp Suite, a comprehensive platform for assessing web application security. It enables cybersecurity professionals to analyze and identify vulnerabilities that malicious actors might exploit. Here are some types of vulnerabilities that might be found during penetration testing using Burp Suite:

Injection Vulnerabilities

  • Injection Vulnerabilities attack at user input fields – like filling out web forms. Instead of filling out an email to subscribe to your newsletters, malicious actors can input commands that interface with your intake form.

  • Burp Suite can identify injection vulnerabilities, such as SQL injection and Cross-Site Scripting (XSS), which can lead to unauthorized data access and manipulation.

Authentication and Authorization Issues

  • Authentication is user verification, and authorization is user permissions or access. Attacks exploit weaknesses in password and verification steps.

  • Burp Suite can pinpoint weaknesses in authentication and authorization mechanisms, helping strengthen access controls and prevent unauthorized access to sensitive data.

Session Management Flaws

  • Session Management concerns user-server interaction and identification – eg, a user logging in to an application. Fixation and hijacking intervenes as the user and server are trrying to legitimately interact.

  • Burp Suite can identify session-related vulnerabilities, such as session fixation and session hijacking, which are critical to ensure user privacy and system integrity.

Information Leakage

  • Information leakage occurs when artifacts from processing protected data are visible and non-random – it’s possible to discern a meaningful and exploitable pattern about underlying information from visible patterns.

  • Burp Suite can detect information leakage points, allowing developers to prevent unintentional disclosure of sensitive information.

Vulnerability Scanning

Vulnerability scanning is another crucial aspect of cybersecurity vulnerability testing. It involves automated scans of medical devices and software components to identify known weaknesses and common vulnerabilities. Some issues that might be uncovered during vulnerability scanning include:

Outdated Software

Default Configurations

Missing Patches and Updates

Vulnerability scanners can identify outdated software and firmware versions that may contain known security flaws. Upgrading to the latest versions can help address these vulnerabilities.

Scanning may reveal devices with default configurations, making them susceptible to unauthorized access. Configurations can be adjusted to enhance security.

Vulnerability scanning can identify missing security patches and updates, which can then be applied promptly to improve device security.

Code Scanning

Code scanning involves reviewing the source code of medical device software to identify security flaws and vulnerabilities. By analyzing the code, cybersecurity experts can discover potential weaknesses that may not be apparent through other testing methods. Common issues uncovered during code scanning include:

Buffer Overflows*

Insecure Data Handling

Poor Input Validation

Code scanning can detect buffer overflows, a type of vulnerability that allows attackers to overwrite adjacent memory and execute malicious code.

The scanning process can identify insecure data handling practices, such as improper encryption or storage of sensitive information.

Code scanning can reveal improper input validation, which can lead to various attacks, including injection vulnerabilities.

*Buffers are temporary memory allocations for data while it’s being moved between processes or from inputs to outputs. They’re well-defined common units and as such are susceptible to exploitation.

Mobile Device Security Testing

Mobile device security testing is essential as mobile devices have become an integral part of health care, facilitating medical professionals' tasks and empowering patients with various health-related apps. However, the increased usage of mobile devices also exposes the health-care sector to potential security threats. To address these concerns, cybersecurity experts conduct mobile device security testing using Mobile Security Framework (MobSF) and mobile device emulation.

Mobile Security Framework (MobSF)

Mobile Security Framework (MobSF) is a powerful open-source tool designed specifically for mobile application security testing. It provides a comprehensive set of functionalities to assess the security of mobile applications, including medical-related apps used in health-care settings. MobSF supports both Android and iOS platforms, making it versatile for evaluating security across a wide range of mobile devices.

Using MobSF, security professionals can perform static code analysis to identify potential security flaws and vulnerabilities in an application's source code. It can detect issues like insecure data storage, sensitive data exposure, improper input validation, and hard-coded credentials. Additionally, MobSF supports dynamic analysis by allowing researchers to install the application on a test device or emulator and interact with it programmatically to assess runtime behaviors. This enables testers to identify runtime vulnerabilities, network-related risks, and potential data leakage points. By leveraging MobSF, health-care organizations can ensure the security and privacy of medical apps, reducing the risk of data breaches and unauthorized access to sensitive health information.

Mobile Device Emulation

Mobile device emulation is a crucial aspect of mobile device security testing. It involves creating virtual environments that replicate the characteristics of various mobile devices, such as different operating systems, hardware configurations, and screen sizes. Emulation enables security professionals to conduct testing in a controlled environment, which is particularly useful when dealing with legacy devices or rare configurations. Emulating different devices ensures that mobile applications are compatible and secure across a diverse range of platforms.

By leveraging mobile device emulation, security testers can simulate various attack scenarios and assess an application's resilience against potential threats. This includes testing for common mobile vulnerabilities, such as insecure data storage, weak encryption, and application tampering. Additionally, mobile device emulation allows testers to evaluate an application's performance under different network conditions, including poor connectivity and network interruptions. This helps identify potential vulnerabilities that could be exploited in real-world scenarios, allowing developers to address them proactively before deploying the application to the public or health-care professionals.

Mobile device security testing, utilizing tools like MobSF and mobile device emulation, is vital to ensuring the security and privacy of mobile applications used in the health care sector. By employing these testing methodologies, health care organizations can identify and address security weaknesses in their mobile apps, safeguard patient data, and provide a secure and reliable platform for health care professionals and patients alike.

Postmarket Survaillance using Security Information and Event Management


Using a Security Information and Event Management (SIEM) system is critical in the battle against cybersecurity threats, and Wazuh is a powerful open-source SIEM platform that offers robust features for enhancing security and compliance in various industries, including health care. Wazuh provides real-time monitoring, threat detection, and incident response capabilities, making it an invaluable tool for safeguarding sensitive data and detecting potential security breaches.

Key Features of Wazuh

  • Log Collection and Analysis: Wazuh collects and analyzes logs from various sources, such as servers, applications, and network devices. This comprehensive log analysis allows security teams to detect unusual activities, potential security incidents, and anomalies that might indicate unauthorized access or malicious actions.
  • Intrusion Detection: Wazuh can detect intrusions and suspicious behavior by correlating data from multiple sources and employing a set of predefined rules and custom rules tailored to an organization's specific needs. This enables early detection of cyber threats, allowing organizations to take immediate action to prevent or mitigate potential attacks.
  • Real-time Alerting: Wazuh provides real-time alerting capabilities, notifying security teams about critical security events over various channels, such as email or Slack, or via integration with other security tools. This proactive approach ensures that security teams can respond promptly to potential threats, minimizing the impact of security incidents.
  • Incident Response: Wazuh facilitates incident response by providing playbooks and automation features that guide security teams through the necessary steps to investigate and mitigate security incidents effectively. These incident response capabilities help organizations reduce the time to detect and respond to cybersecurity threats, limiting the potential damage caused by an attack.

Wazuh for Compliance with NIST, HIPAA, and MITRE

Wazuh can significantly aid organizations in demonstrating compliance with various cybersecurity standards and frameworks, including NIST, HIPAA, and MITRE ATT&CK.

  • NIST: The National Institute of Standards and Technology (NIST) provides cybersecurity guidelines and controls to enhance the security posture of organizations. Wazuh's log analysis and correlation features align with NIST's focus on continuous monitoring and real-time threat detection. Wazuh can assist organizations in meeting NIST's requirements for log management, incident response, and security monitoring.
  • HIPAA: The Health Insurance Portability and Accountability Act (HIPAA) sets security standards for the protection of electronic health information. Wazuh's intrusion detection and log analysis capabilities play a crucial role in monitoring and safeguarding patient data, ensuring compliance with HIPAA's security requirements. Additionally, Wazuh's alerting and incident response features help organizations respond to potential data breaches and security incidents as required by HIPAA.
  • MITRE ATT&CK: The MITRE ATT&CK framework is a knowledge base that describes the tactics, techniques, and procedures used by adversaries in cyberattacks. Wazuh's correlation rules and custom rules can be aligned with MITRE ATT&CK to detect specific techniques employed by threat actors, enabling organizations to proactively defend against these threats.


In conclusion, cybersecurity vulnerability testing is indispensable for ensuring the safety and security of medical devices and their software components. Penetration testing using tools and processes like Burp Suite, vulnerability scanning, and code scanning are crucial for identifying and addressing potential weaknesses. By proactively mitigating cybersecurity risks, the health-care industry can enhance patient safety, protect sensitive data, and maintain trust in medical devices and digital health-care solutions.

Deploying a SIEM system like Wazuh is instrumental in enhancing an organization's cybersecurity defenses. With its real-time monitoring, threat detection, and incident response capabilities, Wazuh can help organizations identify and mitigate potential security breaches promptly. Moreover, its ability to align with cybersecurity standards like NIST, HIPAA, and MITRE ATT&CK enables organizations to demonstrate compliance and maintain a strong security posture, particularly in industries like health care, where protecting sensitive data and ensuring regulatory compliance are of utmost importance.

RQMIS, in collaboration with Twin Tech Labs, has successfully conducted Cybersecurity Testing (Vulnerability & Penetration) for medium- to high-risk cyber devices. Contact us today to help prepare your postmarket cybersecurity surveillance plan and your Premarket submissions!