Ensuring Cybersecurity
of Medical Devices

Keep compliant with latest FDA regulations on cybersecurity and avoid “Refuse to accept” in pre-application

Medical devices are not immune to cyberattacks


    Internet of Medical Things (IoMT)


    Software as a Medical Device (SaMD)


    Connected Medical Devices


of cyberattacks targeted at
hospitals involve an IoMT device


of connected medical devices
contain known critical vulnerabilities

What is FDA asking for?

Starting on 10/01/2023, FDA will issue “Refuse to accept” if you don’t follow:

  • Provide software bill of materials, including commercial, open-source, and off-the-shelf software components;
  • Make a plan to monitor, identify and address postmarket cybersecurity vulnerabilities and exploits;
  • Design, develop and maintain processes and procedures to assure cybersecure of the device and deliver postmarket updates and patches to address new vulnerabilities.
FDA Logo

What Deepbits can deliver?

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    Generate FDA-compliant Software Bill of Materials (SBOM) without the need of source code.

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    Continuous monitor of SBOM for new vulnerabilities, malware and other security threats.

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    Securely distribute SBOM and the latest threat digest to customers.

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    Implemented process and procedures to comply with FDA’s latest regulations on cybersecurity.

Want to know more? Let’s talk

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