HEALTHCARE CYBERSECURITY
What is Medical Device Penetration Testing?
Medical device penetration testing serves as a critical evaluation method for identifying and mitigating vulnerabilities in smart healthcare technology. As healthcare providers increasingly adopt digital solutions, the risk of exposing sensitive patient data or experiencing disruptive security breaches has also escalated. Our services are designed to align with the FDA cybersecurity requirements and NIST Guidance for Health Care Cybersecurity, offering a comprehensive assessment that uncovers actual avenues through which hackers could compromise your medical devices.
In addition to compliance assurance, our medical device penetration testing goes beyond standard vulnerability scanning to offer a multi-layered defense strategy. Utilizing the latest tools and methodologies, we simulate sophisticated cyber-attacks to reveal hidden weaknesses, even in the most secure systems. With a team of certified experts specializing in healthcare cybersecurity, we provide actionable insights and tailored solutions that not only meet but exceed regulatory requirements.
COMPLY WITH FDA’S CYBERSECURITY REQUIREMENTS
The FDA’s Role in Safeguarding
Medical Devices Cybersecurity
The U.S. Food and Drug Administration regulates medical devices and works aggressively to reduce cybersecurity risks in what is a rapidly changing environment. The following medical device cybersecurity awareness video is provided by FDA’s medical device cybersecurity team:
Why Conduct a Penetration Test of Your Medical Devices?

Comply with FDA and other regulatory requirements
Our services will help your organization achieve compliance with FDA requirements and other industry standards by identifying and helping you fix any vulnerabilities currently present in your smart devices. Once our remediation recommendations have been implemented, we will provide an official attestation confirming that you’ve addressed all risks, helping you meet any requirements with ease and confidence.
Identify & fix all existing vulnerabilities
Our team will identify all existing vulnerabilities and security risks within your medical devices and their underlying infrastructure, allowing you to systematically address these issues, strengthen your overall security posture and reduce your overall risk exposure.
Validate existing cybersecurity controls
A penetration test will evaluate the effectiveness of your current security measures, helping you understand whether they are adequate to protect your medical devices from potential threats and improving your ability to prevent attacks.
Test the resilience of your devices against cyberattacks
By simulating targeted attacks in a safe and controlled manner, our penetration testing services will ensure that your medical devices can withstand real-world threats and help develop additional measures to prevent potential disruptions to your patient care, giving you confidence in the security of your devices.
Understand the impact of an attack on your device
Our team of experts will analyze the potential outcome of a successful breach on your medical devices for each vulnerability and security risk that could be exploited by hackers in a real-world scenario, enabling you to prioritize remediation efforts and allocate resources efficiently.
Enhance the security of your device and patients data
By uncovering and addressing vulnerabilities, our penetration testing services will help you enhance the security of your medical data and smart healthcare devices, protecting them from potential disruptions that may disrupt patient care or leak sensitive data.
Services trusted by top medical device manufacturers.




When Should You Perform a
Penetration Test of your Medical Device?
- As part of regulatory or compliance requirements
- Annually as part of a proactive security strategy
- After major changes or updates to the device or infrastructure
- Before deploying a new feature or integration
- Following a security breach or incident
- In response to a new security threat targeting healthcare
Common Cybersecurity Risks & Vulnerabilities Identified
Our methodology covers an extensive attack surface, identifying vulnerabilities that are unique to your medical device, as well as the most commonly found security risks in modern smart devices:
Insecure communication protocols
A security risk where attackers exploit weak or unencrypted communication channels between medical devices and other systems, potentially intercepting sensitive data or manipulating device operations.
Unsecured wireless communications
A security risk where wireless communication between medical devices and other systems is not properly secured, enabling attackers to intercept data, inject malicious payloads, or disrupt device functionality.
Insufficient access control
Insufficient Access Control is a security vulnerability specific to medical devices where inadequate safeguards allow unauthorized users to gain access to sensitive functionalities. This opens the door for potential exploitation, endangering both the integrity of the device and the safety of patient data.
Exposed cloud infrastructure
A security risk where medical devices or their associated data are stored in improperly configured cloud environments, leaving them vulnerable to unauthorized access, data breaches, or other malicious activities.
Lack of encryption for sensitive data
A vulnerability that occurs when sensitive data, such as patient information, is stored or transmitted without proper encryption, making it easier for attackers to intercept, access, and misuse the data.
Vulnerable configurations and settings
A vulnerability that exists when medical devices are deployed with insecure default settings or configurations, potentially exposing them to unauthorized access or other security risks.
BEST PRACTICES
Build Secure & FDA-Compliant
Medical Devices
Limit access to trusted users through passwords, usernames, smartcards, biometrics, automatic timers, and physical locks.
Ensure that only trusted content is within the device and/or system by measures such as restricting updates to the same or using encryption.
Detect and respond to hacking attempts with security compromise alerts.
Leverage a structured and systematic approach to identify, characterize, and assess cybersecurity vulnerabilities.
DID YOU KNOW?
a known critical vulnerability. ”
Need to Conduct a Penetration Test of Your Medical Device?
The FDA's Regulations For
Medical Device Cybersecurity
FDA's Premarket Guidance:
- Perform a risk assessment to identify potential cybersecurity vulnerabilities.
- Develop a risk management plan to mitigate identified risks.
- Provide documentation to support the cybersecurity measures implemented.
FDA's Postmarket Guidance:
- Implement a robust cybersecurity risk management program.
- Monitor and detect cybersecurity vulnerabilities.
- Assess the risk of identified vulnerabilities and implement appropriate actions.
- Communicate and collaborate with stakeholders for coordinated vulnerability disclosure.
Frequently Asked Questions
Couldn’t find the information you were looking for? Ask an expert directly.
The purpose of a medical device penetration test is to identify vulnerabilities and weaknesses in medical devices, ensuring their security, reliability, and compliance with industry standards and regulations (e.g., FDA, HIPAA) to protect patient data, maintain patient safety, and prevent unauthorized access or malicious activity.
A medical device penetration test is performed using a combination of automated vulnerability scanning tools and manual testing techniques by security experts, who assess the device’s hardware, firmware, software, network communication, and data handling for potential vulnerabilities.
You should have a functional medical device or prototype, access to relevant firmware or source code, and any necessary documentation, such as technical specifications or API documentation, to enable a thorough assessment of the device’s security.
Yes, you’ll need to grant our team appropriate access and permissions to your smart device, networks, and systems to ensure a thorough and accurate assessment. In most cases, it is not required for you to physically ship the device for us to conduct the test. Our team will offer various solutions to access it remotely, but in the event that only physical testing can be performed for your specific type of device, all requirements and details will be discussed with your team in a pre-launch team. The device can be sent to the Vumetric office where it will be assessed in-person by a specialist.
Yes, a medical device penetration test can assess the security of both standalone and connected devices, as it examines various aspects of the device, such as hardware, firmware, software, and network communication, to identify vulnerabilities and potential risks.
A medical device penetration test helps ensure compliance with various regulatory standards, such as FDA and HIPAA, by identifying security gaps and providing remediation guidance. Demonstrating adherence to security best practices and proactively addressing vulnerabilities can also support audits and certifications.
The duration of the test depends on the complexity of the medical devices and the scope of the assessment. Typically, it may take anywhere from a few days to several weeks to complete.
We can perform penetration test of a wide range of medical devices, including remote patient monitoring systems, robotic surgery equipment, and connected devices, among others. Vumetric is the pentest provider with the most extensive experience in the field of penetration testing for medical devices and our team can confidently test and secure any type of smart healthcare equipment.