Identify. Exploit. Secure. Protect Patient Safety.

    Medical Device Penetration Testing

    At Cyberintelsys , we specialize in securing medical devices and healthcare technology ecosystems through comprehensive Medical Device Penetration Testing (MD VAPT). Our experts uncover vulnerabilities across embedded systems, IoT-enabled devices, wireless interfaces, applications, and hospital network integrations to help organizations strengthen defenses before attackers exploit weaknesses.

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    What is Medical Device Penetration Testing?

    Medical Device Penetration Testing is a controlled cybersecurity assessment designed to simulate real-world cyberattacks on medical devices and supporting infrastructure. It evaluates how effectively devices and connected systems can withstand unauthorized access, exploitation, and misconfigurations.

    This testing helps manufacturers, hospitals, and healthcare providers:

    • Identify and validate device vulnerabilities
    • Assess compliance with FDA cybersecurity guidance, IEC 62304, ISO 14971, and HIPAA
    • Protect patient safety and device reliability
    • Strengthen regulatory submissions and post-market security posture

    Patient Safety First

    Protects patients by identifying flaws that could lead to unsafe device behavior, denial of therapy, or manipulation of clinical data.

    Regulatory Compliance & FDA Readiness

    Supports compliance with FDA premarket/postmarket cybersecurity guidance, ISO 14971 (risk management), IEC 62304 (software lifecycle security), and healthcare cybersecurity frameworks.

    Vulnerability Identification & Prioritization

    Reveals weaknesses across firmware, wireless communication, mobile apps, APIs, cloud integration, and hospital network connections. Vulnerabilities are categorized and prioritized by criticality and clinical impact.

    Actionable Security Insights

    Delivers detailed technical reports and remediation guidance, enabling engineering and product security teams to address vulnerabilities effectively.

    Testing Coverage Areas

    A secure medical device ecosystem requires testing every component — inside and out. Our assessments include:

    Firmware & Embedded System Security Testing
    Wireless Communication & (BLE) Security
    Mobile Application Security
    API & Cloud Service Security Testing
    Hospital Network Integration & Data Flow Security
    Physical Interface Testing
    Protocol Security Review
    Post-Market Vulnerability Assessment
    Our Medical Device Security Testing Approach
    At Cyberintelsys, we safeguard medical devices with a specialized security testing framework. Our comprehensive penetration testing and vulnerability assessments are tailored to the unique risks of healthcare technology, ensuring device integrity, patient safety, and regulatory compliance.
    We define objectives, in-scope assets (devices, applications, protocols, integrations), and authorized testing methods, ensuring alignment with regulatory and safety constraints.
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    Client Experiences With Our Testing Process

    Our clients rely on us to secure their critical applications and protect their data. Hear what they have to say about our expertise, dedication, and the impact of our web application penetration testing services.

    Saravana Ganesh
    Saravana Ganesh
    Exceptional Expertise and Support
    ☆ ☆ ☆ ☆ ☆

    We sincerely appreciate the exceptional expertise, clear communication, responsiveness, and flexibility shown throughout this project. Your active involvement played a vital role in making it a success. We also extend our gratitude to your management team for their support.

    Shashan Ram
    Shashan Ram
    Truly Satisfied with the Outcome
    ☆ ☆ ☆ ☆ ☆

    Thanks a bunch — this truly satisfies all of our current requirements. The team was amazing! It was a pleasure working with you, and I would love to collaborate again in the future for any upcoming requirements.

    Rahul
    Rahul
    Professional and Dedicated Team
    ☆ ☆ ☆ ☆ ☆

    Great work! Thanks a lot for the speedy delivery and consistent support throughout the project. Your professionalism and dedication are truly appreciated.

    Sandeep
    Sandeep
    Seamless Project Execution
    ☆ ☆ ☆ ☆ ☆

    Excellent work! The team’s responsiveness, attention to detail, and proactive approach made the entire project seamless. We truly value the effort and support provided throughout.

    Improved Patient Safety & Trust

    Secures device integrity and reliability.

    FDA Submission & Post-Market Support

    Helps prepare regulatory documentation and continuous monitoring strategies.

    Regulatory Compliance

    Aligns with FDA, HIPAA, ISO 14971, IEC 62304, NIST CSF, and AAMI TIR57.

    Cost Savings

    Prevents costly recalls, regulatory penalties, and patient harm incidents.

    Comprehensive Security Assessment

    Evaluates device, network, cloud, and application components.

    Security by Design Validation

    Ensures cybersecurity is embedded into device lifecycle, from development to deployment.

    Business & Regulatory Benefits
    Different Types of Medical Device Penetration Testing

    Black Box Testing

    Simulates external attackers with no prior knowledge of the device or ecosystem. Tests exposed services, APIs, and wireless interfaces.

    White Box Testing

    Performed with full documentation, firmware access, and architectural knowledge. Deep testing of software/firmware security and lifecycle vulnerabilities.

    Gray Box Testing

    Replicates insider threats or partial knowledge attacks (e.g., compromised credentials, limited device access).

    Explore Our Important Resources And Reports
    Case Study (2)
    First-Time Penetration Testing Buiyer Guide

    Read the essential with our go-to guide to your first penetration test, everything you need to know to make an informed and successful investment in your security

    Download
    Case Study (2)
    First-Time Penetration Testing Buiyer Guide

    Read the essential with our go-to guide to your first penetration test, everything you need to know to make an informed and successful investment in your security

    Download
    Case Study (2)
    First-Time Penetration Testing Buiyer Guide

    Read the essential with our go-to guide to your first penetration test, everything you need to know to make an informed and successful investment in your security

    Download
    Case Study (2)
    First-Time Penetration Testing Buiyer Guide

    Read the essential with our go-to guide to your first penetration test, everything you need to know to make an informed and successful investment in your security

    Download
    Case Study (2)
    First-Time Penetration Testing Buiyer Guide

    Read the essential with our go-to guide to your first penetration test, everything you need to know to make an informed and successful investment in your security

    Download
    Our Proven Process for Medical Device Security Testing
    Our structured, step-by-step process ensures every potential vulnerability in medical devices is identified and addressed. We prioritize risks, strengthen device security, and safeguard against evolving cyber threats. From initial consultation to retesting, we ensure your medical devices remain resilient, compliant, and secure.
    1. Initial Consultation & Requirement Gathering

    Collect details on device design, usage, protocols, and regulatory requirements.

    2. Scoping & Planning

    Define scope (devices, apps, cloud services, hospital integrations), testing limits, and safety precautions.

    3. Reconnaissance & Enumeration

    Map attack surface across firmware, apps, APIs, and networks.

    4. Vulnerability Assessment

     Identify security flaws, outdated components, and misconfigurations.

    5. Manual Exploitation & Attack Simulation

    Controlled exploitation simulating real-world adversaries while preserving device safety.

    6. Risk & Patient Safety Impact Analysis

    Prioritize findings based on safety, compliance, and business risk.

    7. Reporting & Remediation Guidance

    Deliver comprehensive reports with remediation mapped to FDA & ISO requirements.

    8. Retesting & Continuous Improvement

    Validate remediation and support post-market surveillance and ongoing compliance.

    Protect Your Business from Emerging Cyber Threats

    Cyberintelsys helps you stay one step ahead of today’s advanced cyber risks. Our expert-led penetration testing and security assessments are designed to identify vulnerabilities before attackers do — helping you strengthen your security posture and meet compliance standards. Fill out the form, and we’ll get back to you with a tailored solution.

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    Frequently Asked Questions

    Quick Answers to Your Medical Device Concerns
    We require device documentation, supported communication protocols, deployment environment, regulatory requirements, and intended use.

    It depends on device complexity, integrations, and testing depth. Engagements typically last from 2 weeks to several months.

    No. All testing is conducted in controlled environments or with non-intrusive techniques. Patient safety is always the top priority.

    Firmware flaws, insecure wireless communications, mobile app/API weaknesses, outdated libraries, insecure cloud integrations, and risks of patient data exposure or unsafe therapy manipulation.
    A detailed technical report with findings, severity ratings, patient safety impact analysis, remediation guidance, and a management-level presentation for stakeholders and regulators.