Ensuring Cybersecurity
of Medical Devices
Keep compliant with latest FDA regulations on cybersecurity and avoid “Refuse to accept” in pre-application
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
88%
of cyberattacks targeted at
hospitals involve an IoMT device
53%
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.
What Deepbits can deliver?
Generate FDA-compliant Software Bill of Materials (SBOM) without the need of source code.
Continuous monitor of SBOM for new vulnerabilities, malware and other security threats.
Securely distribute SBOM and the latest threat digest to customers.
Implemented process and procedures to comply with FDA’s latest regulations on cybersecurity.
