MEDICAL DEVICE CYBERSECURITY

Get cyber-secure, cyber-compliant medical devices to market

Manage SBOMs and vulnerabilities for all products and business units, and automatically validate compliance with medical device regulations such as
FDA requirements, all from one place.

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Cybersecurity -
one of the biggest challenges for getting devices to market

Cybersecurity is becoming the single biggest inhibitor for releasing medical devices and keeping them operational. New FDA regulations and investigations, rising time to market pressures, and strict SBOM requirements are forcing manufacturers to make costly compromises. When more and more devices are software-defined, how can we ensure medical device cybersecurity and safety, while also preventing costly recalls and delays?

The Product Security Platform

Your center for everything
medical device cybersecurity

Manage SBOMs across teams

Churn out quality SBOMs you can rely on - Get a high level view of your entire SBOM validation process, and track the progress across teams and business units

Automate compliance validation

Use pre-mapped requirements of medical device regulations such as the FDA Premarket Guidance to automatically identify compliance gaps and produce audit-ready reports in a click of a button

Continuously monitor for cyber risks

Understand exactly which products are affected by a new vulnerability, and conduct detailed investigations, accelerating pre and post market cybersecurity

Discover the platform

This platform is way more comprehensive than anything I’ve seen available on the market

Chris Gates |
Director of Product Security, Medical Device Cybersecurity Advisor

Cybellum’s platform allows the team to detect and mitigate risks early and often

Supermicro’s software security team

Medical device cybersecurity,
simplified.

Manage risk across BUs and product lines

Quickly identify the most critical issues across all your medical devices and teams, from security issues to compliance gaps and supply chain risks

Stay compliant, for good

Keep all products and components compliant with medical device regulations, standards, and best practices such as the FDA Premarket and Postmarket Guidance, IMDRF and EU MDR/IVDR

Secure across the entire lifecycle

Detect and mitigate medical device security vulnerabilities, coding weaknesses and malware from design to post-production, manage SBOMs, and facilitate post-market incident response, all from one place

What makes it all possible

Cyber Digital Twins™ technology creates exact digital replicas of your medical device’s software, allowing you to analyze, detect and manage cyber risks in incredible detail, from a single component level, all the way to a full product system

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