In September of 2023 the FDA finalized a new cybersecurity guidance titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions“, which replaced the previous cybersecurity guidance from 2014. Minnetronix has been preparing for this new guidance since the original draft was released in 2022, with the biggest change being the establishment of the Secure Product Development Framework (SPDF), which addresses the following considerations:
- Security Risk Management
- Security Architecture
- Cybersecurity Testing
To learn more about the Minnetronix process for safeguarding medical devices from cybersecurity threats and vulnerabilities, fill out the form below to receive a PDF version of the paper.