FDA-compliant PKI-based authentication for medical devices, enabling device provisioning, ensuring secure communication and regulatory compliance without disrupting performance.
Three of the top five medical device manufacturers trust Guardian's proven platform to meet FDA's Section 524B requirements. Our comprehensive PKI-based security covers your entire device lifecycle - from development through post-market surveillance.
Guardian provides a comprehensive device security platform, combining a flexible software library and robust cloud infrastructure. Provision devices with unique cryptographic identities, enabling secure cloud authentication and controlled access.
North-South protection (device-to-cloud security)
Ensure secure communication between devices and cloud platforms over a private network or internet.
Both unidirectional and bidirectional traffic between endpoints can be supported over various transport technologies.
East-West protection (local network security)
Ensure encrypted and authenticated communication between components of devices. Guardian also can integrate to help secure communication protocols such as DDS.
In 2023, the PATCH Act granted the FDA legal authority to enforce medical device cybersecurity. As of October 2023, the FDA began issuing notices to manufacturers failing to meet new security standards in 510(k) submissions.
MDMs should also prepare to meet requirements in the Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (Draft, March 2024). Key enforcement areas include:
Cybersecurity integrated from the start of development.
Only authorized users and devices can access the system.
Enforcing appropriate access levels.
.png){kind=spacer}
Protecting sensitive data.
.png)
Ensuring data and system functions remain unaltered.
Medcrypt’s Guardian works side-by-side with RTI Connext’s Security Extensions to provide a comprehensive solution. This integrated solution ensures that medical device manufacturers can effectively secure their devices and meet FDA requirements, potentially avoiding the numerous deficiencies that many are currently facing.
Medical device manufacturers face a multitude of challenges when it comes to ensuring their devices meet stringent cybersecurity requirements. Some of the key challenges include:
Medcrypt’s Guardian Platform — featuring Guardian Library, Agent, Cloud, and Vault — addresses the most complex security challenges, ensuring compliance with regulatory standards and securing your devices. Guardian is designed to seamlessly integrate with your device's cryptographic libraries, offering flexibility and cost-effectiveness, which shortens development time while maintaining robust security.