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visibility | scalability | compliance

Meet the FDA's cybersecurity standards and gain software supply chain visibility

Finite State’s end-to-end SBOM solutions deliver SBOM generation, ingestion & management for faster mitigation and time-to-market for medical device manufacturers.

Finite State empowers manufacturers to meet the FDA's stringent medical device cybersecurity standards and expedite the approval process.

For medical device manufacturers, delivering high-quality, secure, and innovative products to the market in a timely manner is crucial. And the FDA's adoption of Section 524B, focusing on the security of these vital instruments, has ushered in a new era of stringent enforcement. Product Security teams often have limited visibility into threats and compliance, because they’re focused on a ship date. Finite State solves this lack of visibility into software supply chains and helps protect against potential loss of revenue, giving security teams a unified and prioritized risk view.

Our medical device customers come to us because we understand the importance of a secure-by-design strategy in the context of medical devices and FDA regulations. And traditional AppSec tools struggle to provide adequate security coverage that spans the software supply chain security lifecycle.

Through best-of-breed binary software composition analysis (SCA) that's complemented by static application security testing (SAST) and end-to-end software bill of materials (SBOM) solutions, Finite State provides a comprehensive list of a device's software components and versions. This helps to identify and address potential security vulnerabilities, comply with regulations, and improve supply chain transparency.  

We also help you track the use of open-source software in your products, which is critical for compliance with open-source licenses.

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If you are trying to reduce risk created by first or third party software, we can show you how our medical device manufacturing customers are using our comprehensive SCA solution to generate SBOMs, locate vulnerabilities in the portfolio, and create a plan for remediation.

Medical Device Security Resources

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2023 State of Cybersecurity for Medical Device Manufacturers

Report

2023 State of Cybersecurity for Medical Device Manufacturers
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A Holistic Approach to Decrease Attack Surface & Improve Patient Safety

On-Demand Webinar

A Holistic Approach to Decrease Attack Surface & Improve Patient Safety
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Finite State Platform for Medical Device Manufacturers

Datasheet

Finite State Platform for Medical Device Manufacturers
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Eliminating FDA 524B “Refuse to Accept” Obstacles

Data Sheet

Eliminating FDA 524B “Refuse to Accept” Obstacles
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The Complexity of IoT Device Vulnerability & Future of Medical Device Security

On-Demand Webinar

The Complexity of IoT Device Vulnerability & Future of Medical Device Security
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The FDA Will Soon Require SBOMs for Medical Devices. Are You ready?

Podcast

The FDA Will Soon Require SBOMs for Medical Devices. Are You ready?

A Full Context Approach

The Finite State platform provides comprehensive product security across the entire software supply chain security lifecycle for leading medical device manufacturers with diverse, fragmented supply chains. We do this with extended SBOM management that ingests and aggregates data from over 120 external sources providing remediation guidance that aggregates and reconciles results across all scans.

Update Overview Designs for S4 Scope - ASOC-286 (1)

 

Key Features

Software Composition Analysis delivers:

  • SBOMs: (Software Bill of Materials) Full visibility into all software components such as binaries, libraries, open source software (OSS), third-party components, embedded software, drivers, etc.
  • Visibility into Third Party & Open Source Risk: Security risks inherited by your vendors and suppliers, including legal & compliance  risk from unknown, undisclosed, or expired licenses
  • Robust VEX Support: Insecure configurations, hard coded credentials, cryptographic materials, and other possible sources of weakness
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Comprehensive Risk Profile

A unified view of your product and supply chain risks with a risk score that indicates level of urgency. You get a streamlined scoring methodology that effectively conveys risk levels of a product or asset through a straightforward numerical scale, backed by sophisticated risk prioritization.

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Issue Management

Advanced remediation guidance that de-dupes and reconciles results across all scans, generated or ingested, for context-aware recommendations. A way to quickly prioritize and manage security issues. Reduce friction between development teams and product security teams by providing remediation guidance with the largest risk reduction ROI.

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Compliance Guidance

Meet regulatory requirements with essential  information necessary so teams can address compliance gaps across the automotive, energy and medical device industries.

FDA Section 524B
NERC CIP-013
And more
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Advanced Reporting & Analytics

Enhanced SBOM capabilities to decompose a product or asset into its many components for a laser-focused risk assessment, or a Summary Report for business leaders. Guided by our intuitive scoring system, share insights and analytics with internal and external stakeholders via our easy and robust reporting function.

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