Secure Medical Devices: Compliant and Protected Against Cyberattacks

Penetration Testing with TÜV SÜD: For Patient Safety in a Connected World and for FDA & CE Certification.

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Penetration Testing with TÜV SÜD: For Patient Safety in a Connected World and for FDA & CE Certification.

Cybersecurity with TÜV SÜD: Penetration Testing in Line with MDR and FDA Requirements – and Protection Against Digital Threats

Medical device manufacturers must comply with strict regulatory cybersecurity requirements, including penetration testing. These measures are essential e.g. for MDR and FDA certification. Non-compliance can lead to significant delays or restrictions to market entry.

Cyber Risks Regulations
We observe that the FDA increasingly refuses certification of medical devices if no cybersecurity tests have been carried out for central attack vectors such as USB, BLE or update mechanisms. TÜV SÜD has extensive experience in IoT and medical communication protocols such as HL7 and SDC – and supports manufacturers in meeting regulatory requirements with confidence.
Kuefner

Jan Küfner

TÜV SÜD Penetration Testing Services

Alongside stricter regulations, the risk of cyberattacks is rising globally. Such attacks can lead to financial losses, product recalls, and diminished trust among patients and customers.

TÜV SÜD's penetration testing is designed so that the results can be used for MDR and FDA certifications. This enables you to bring your products to market efficiently.

Trust in Numbers: Global Cybersecurity with TÜV SÜD

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Why You Can Trust TÜV SÜD

  • Pictogram in .SVG for Regulatory Compliance

    Regulatory Expertise

    We have a deep understanding of the MDR & FDA regulatory landscape and the state of the art for cyber security in medical devices.

  • Pictogram in .SVG for Certified Document

    Efficient Approval Preparation

    Our recognised test reports can be used for MDR and FDA certification. – saving you effort.

  • Pictogram in .SVG for Save Time

    Fast and Targeted Execution

    With extensive experience in connected medical technology, we deliver efficient, application-specific testing at optimised speed.

  • Pictogram in .SVG for Regulatory Complexity

    Clear Safety Benefits

    Our test reports give clear and detailed insights to your products vulnerabilities.

  • Pictogram in .SVG for Trust, Credibility and Security Validation

    Trust Advantage with TÜV SÜD

    The TÜV SÜD brand enhances your credibility with customers and partners worldwide.

Our cybersecurity experts uncover vulnerabilities in your medical devices through penetration testing in our laboratories. These risks are addressed before they can threaten patients, products, or your company's reputation.

We provide clear evidence on your devices vulnerabilities. 

Thanks to our knowledge exchange with Notified Bodies, our specialists are highly familiar with MDR and FDA requirements. They tailor penetration tests acc. to state of the art to meet regulatory requirements. TÜV SÜD penetration test reports can therefore directly be used in your technical documentation.

With TÜV SÜD's high-quality penetration testing services, you can reduce risks and improve your market opportunities in measurable ways.

Secure your medical device

Compliant and protected against cyberattacks
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    Penetration Testing: The Process in Six Steps

    A penetration test at TÜV SÜD follows six steps: after initial planning and target definition, our experts simulate attacks to identify vulnerabilities in your system.

    The results are analysed in detail and documented in a comprehensive report, which you can use for your certification submission (e.g. MDR or FDA). Our documentation is suitable for all global regulations.

    Cybersecurity Info_Process

    Our Penetration Testing Services for Your Cybersecurity and Market Approval

    • What we test
      Attack vectors such as GUI, USB, UART, BLE or Ethernet, and both standard and medical-specific protocols such as FHIR, DICOM, SDC, MQTT, etc.
    • How we test
      According to recognised standards such as OSSTMM, OWASP, PTES, MASTG, UL 2900-2-1. And IEC-TR 60601-4-5, IEC 81001-5-1 under ISO 17025:2018 accreditation.
    • How much we test
      We can adapt our testing depth and methods to your needs.
    More and more customers approach us after FDA rejections due to inadequate or faulty penetration testing. We support these clients by conducting tests effectively, fully aligned with FDA requirements, helping them achieve successful submissions.
    Malte

    Malte Knowles Schmidt

    Global Portfolio Manager Cybersecurity

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    Disclaimer:
    TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognized Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs