Keep compliant with latest FDA regulations on cybersecurity and avoid “Refuse to accept” in pre-application
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
Starting on 10/01/2023, FDA will issue “Refuse to accept” if you don’t follow:
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.