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Medical Device Penetration Testing Services

Our medical device penetration testing services identify & fix real-world opportunites for hackers to breach healthcare equipment and disrupt patient care, providing detailed recommendations to prevent incidents.

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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.


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?

By conducting medical device penetration testing, organizations can gain valuable insights into the security posture of their healthcare equipment, ensuring the safety and privacy of patients. Here is what you will get after conducting a project with our team:

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.

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.

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.

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. 

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.

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?

Medical devices should be tested on a regular basis to identify and address newly discovered or introduced vulnerabilities in your technologies and stay up to date with the latest security threats.

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:

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.

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 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.

 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.

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.

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.


Build Secure & FDA-Compliant
Medical Devices

Our medical device security testing services ensure that you meet the FDA’s 26 device hardening best practices, along with key industry standards. Our hands-on approach stretches across proprietary hardware components, as well as network services to maximize the identified vulnerabilities.

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.


Need to Conduct a Penetration Test of Your Medical Device?

The FDA's Regulations For
Medical Device Cybersecurity

FDA's Premarket Guidance:

Provides recommendations for medical device manufacturers to address cybersecurity risks during the design and development of their products.

FDA's Postmarket Guidance:

Aims to maintain the security of medical devices throughout their lifecycle.

Frequently Asked Questions

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What is the purpose of conducting a penetration test of your medical device?

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.

How is it performed? What is the process?

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.

What are the requirements to get started?

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.

Do we need to provide any access or permissions for the test to be conducted?

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.

Can a medical device penetration test cover both standalone and connected devices?

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.

How can it help us meet compliance requirements?

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.

How long does it take?

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.

What types of devices can be pentested?

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.

Professional Reporting With Clear & Actionable Results

Our penetration reports deliver more than a simple export from a security tool. Each vulnerability is exploited, measured and documented by an experienced specialist to ensure you fully understand its business impact.

Each element of the report provides concise and relevant information that contributes significantly towards improving your security posture and meeting compliance requirements:

Executive Summary

High level overview of your security posture, recommendations and risk management implications in a clear, non-technical language.
Suited for non-technical stakeholders.

Vulnerabilities & Recommendations

Vulnerabilities prioritized by risk level, including technical evidence (screenshots, requests, etc.) and recommendations to fix each vulnerability.
Suited for your technical team.


This document will allow you to meet compliance and regulatory reporting requirements efficiently and with minimal overhead.
Suited for third-parties (clients, auditors, etc).


Empowering Your Cybersecurity, Our Mission

Our ISO9001-certified cybersecurity services are trusted by more than 400 organizations each year, including SMBs, Fortune 1000 companies, and government agencies.

CERT Accredited Cybersecurity Company

Vumetric, Leader in Medical Device Penetration Testing

Vumetric is a leading cybersecurity company dedicated to providing comprehensive penetration testing services for over 15 years. We pride ourselves on delivering consistent and high-quality services, backed by our ISO9001 certified processes and top industry standards.

100% dedicated to pentesting

No outsourcing

No resell of material / software

Transparency & reputation

Actionable results

Certified experts

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