Medical Device Security
Assessment & Mitigation

Manage vulnerabilities and validate compliance at scale

SANITIZING MEDICAL DEVICES IS NO LONGER OPTIONAL

The vision of connected healthcare is turning into a reality, giving rise to the Internet of Medical Things (IoMT). But with it come challenges - clinical networks and assets are subject to repeat cyber attacks, even more so in these days of global pandemic, risking patient care and operations.

Healthcare organizations and regulators are pressuring medical device OEMs and their suppliers to accelerate innovation while keeping IoMT devices safe, secure and compliant. But as OEMs rise to the challenge, leveraging 1st and 3rd party software (commercial and open-source) to become more agile, there’s a growing risk of introducing vulnerabilities that endanger equipment and patients.

To safeguard their customers, comply with regulation and remain competitive, all stakeholders in the medical device supply-chain must become cyber-responsible organizations. Fail to do so, and they risk unsustainable exposure to regulatory violations, liability claims, brand equity erosion and more.

CURRENT VULNERABILITY
MANAGEMENT ECONOMICS
DON’T WORK

The growing scale, diversity and complexity of embedded software keeps pressuring connected medical device (IoMT) manufacturers to manage vulnerabilities before they become exploitable.

CIOs, CISOs and Product Security leaders are growing frustrated with a software supply chain they are effectively blind from (often available in binary form only), challenged by tools that don’t scale and overwhelmed with numerous regulations, standards & internal policies.

Current approaches are:

  • Time consuming – manual monitoring and analysis of new and evolving threats is slow, expensive and ineffective.
  • Unproductive – traditional tools don't provide the context needed to prioritize and respond to imminent threats
  • Inconsistent – one-off efforts won’t secure products for long, putting at risk the safety of equipment and well-being of patients

Security teams must adopt processes and technologies that scale within and across development programs, enabling them to continuously detect and remediate the most pressing vulnerabilities, while adhering to stringent healthcare regulations and standards.

Cybellum

DOWNLOAD ASSET SECTION

eGuide: The X steps you need to nail to properly manage vulnerabilities in the automotive industry.

MEDICAL DEVICE CYBER SECURITY REIMAGINED

Cybellum enables medical device OEMs and their suppliers to produce and maintain secure IoMT products. Through patent pending Cyber Digital Twins™ technology, our solutions provide the visibility, context and agility you need to scale vulnerability management and compliance validation, so devices remain safe and secure throughout their entire operational lifespan.

CYBELLUM PRODUCT ASSESSMENT AND OPERATIONS

CONTINUOUSLY TRACK VULNERABILITIES

Monitor new and evolving vulnerabilities in real time via multi-source aggregation of threat intelligence.

UNDERSTAND CONTEXT & PRIORITIZE

See if and how vulnerabilities and security gaps impact IoMT security across your organization to prioritize mitigation efforts.

ACCELERATE CERTIFICATION

Validate compliance and speed-up auditing for multiple healthcare regulations and standard with minimal manual efforts.

FACILITATE maintenance & SUPPORT

Automatically assess vulnerability impact on in-service equipment and get mitigation advice so it remains safe & secure. 

Cybellum for medical devices

TRUSTED BY
INDUSTRY
LEADERS

Software risk management is becoming evermore critical to Medical and Industry 4.0 stakeholders. Cybellum brings vital visibility into the modern software supply chain, proven vulnerability management, and extraordinary cybersecurity expertise.

Philipp Unterhalt, Managing Director, Hahn Group

Download asset section

eGuide: The X steps you need to nail to properly manage vulnerabilities in the automotive industry.

UNDER THE HOOD

  1. CYBER DIGITAL TWINS™ - Cybellum uncovers all characteristics of product software within device firmware. No source code needed. 
    We create an accurate replica of each product component (including C-SBoM, licenses, hardware architectures, OSs, configurations, control flow, API calls), providing the transparency and traceability needed for detailed security analysis.
  2. INTELLIGENCE DRIVEN DEFENSE – aggregating multiple public and proprietary threat intelligence feeds along with insights from the Cybellum Research Lab, we track new vulnerabilities, changes to existing threats and new attack methods.
  3. AGENTLESS EXPOSURE – our backend solutions integrate seamlessly with your SDLC workflows, automatically exposing threats and policy violations, providing a full impact analysis on components & devices.
  4. RISK-BASED PRIORITIZATION – by understanding the full context in which device components operate, we filter out irrelevant vulnerabilities, enables risk-based prioritization of efforts and provides value-added mitigation recommendations.

COMPLIANCE COMES
STANDARD

Cybellum helps you navigate compliance with major industry regulations, standards and best practices such as FDA-2018-D-3443 (Premarket Submissions for Management of Cybersecurity in Medical Devices), FDA-2015-D-510 (Postmarket Management of Cybersecurity in Medical Devices), MDCG 2019-16 (European Commission Guidance on Cybersecurity for Medical Devices) and UL 2900. Cybellum covers risk assessment and vulnerability management, all the way to auditing and documentation.

Cybellum

Continuous
Visibility

Uncover the hidden software supply chain & expose security gaps through binary code analysis

Cybellum

Insight &
Focus

Bring context into chaos
by understanding vulnerability impact
and prioritizing remediation

Cybellum

security at
scale

Cut complexity, time and cost of security assessments and maintenance  & support operations  


Cybellum

PRODUCT SECURITY ASSESSMENT

SECURE FROM
DESIGN TO THE ER

Cybellum eliminates risks throughout the device lifespan - from development  and integration all the way through production, maintenance & support

Cybellum

PRODUCT SECURITY OPERATIONS

FIRM UP YOUR FIRMWARE AND

MANAGE YOUR CYBER RISK.