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
🚀 Start Compliance CheckMedical 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.
Stay Compliant with Federal Regulations
Ensure your medical devices meet all FDA cybersecurity requirements to avoid rejection and maintain compliance.
What Deepbits
can deliver?
Comprehensive cybersecurity solutions for medical device compliance
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.
Ready to ensure FDA compliance?
Get started with our comprehensive cybersecurity solutions for medical devices
🚀 Start Your AssessmentWant to know more?
Let's talk
Ready to secure your medical devices and ensure FDA compliance? Our cybersecurity experts are here to help.