For Medical Devices

Treat Product Cybersecurity and Compliance With Care

Ensure your medical devices are secure and market-ready with ONEKEY. Our platform supports your FDA and EU MDR compliance efforts by generating and validating SBOMs, and detecting vulnerabilities throughout all stages of development and continuous digital-twin monitoring after release. Stay ahead of regulatory demands and protect patient safety with our precision tools made for the medical industry.

Medical

The Cost of Lacking Cybersecurity and Compliance in Medtech

Identifying and mitigating risks in healthcare settings is critical, yet labor-intensive and expensive – leading to recalls that harm your reputation.

Challenge 1

Multiple components with various supply chains exponentially increase the complexity of vulnerability analytics and prioritization. Manual triage and keeping up with evolving cybersecurity requirements, including SBOM management is tedious and fallible.

Challenge 2

Securing medical devices throughout their lifecycle requires constant vigilance - from initial design to post-market. Vulnerabilities can arise at any stage, and managing them effectively is both critical and challenging.

Challenge 3

Third-party components in medical device software significantly increase cybersecurity risks. Managing these elements to ensure compliance with security standards and address vulnerabilities throughout the supply chain is a complex task.

Diagnose & Treat Cyber Risks in Your Medical Devices

SBOM

Automate Your Software Supply Chain Security

ONEKEY's automated Software Bill of Materials (SBOM) provides deep visibility into the software supply chain for device manufacturers – across all teams. Gain detailed insight into your firmware, efficiently audit third-party components and make informed, secure decisions. Reduce the risk of cyber-attacks and avoid loss of data or efficiency.

Automate Your Software Supply Chain Security
Zero-Day Detection

Uncover Unknown Threats for IoT/OT

Discover automated zero-day vulnerability analysis for medical smart devices and control systems. Identify unknown vulnerabilities to pre-empt attacks and improve security. Zero-day detection includes scripts and binaries for issues such as command injection, insecure communication or hardcoded credentials. Benefit from precise static code analysis that traces data flow, highlighting potential injection vulnerabilities and facilitating swift mitigation.

Uncover Unknown Threats for IoT/OT
Automated Vulnerability Analysis

Accelerate Your Cybersecurity Management

Let our ONEKEY platform detect and prioritize firmware vulnerabilities of your medical device for you. Reduce remediation time and proactively protect your assets from cyber threats, 24/7. Ensure your assets stay secure from cyber threats in an automated, highly efficient manner.

Accelerate Your Cybersecurity Management

ONEKEY Platform for Medical Device Manufacturers

Efficient Product Cybersecurity

Efficient Product Cybersecurity

Identify vulnerabilities, fast – in one place. Our platform provides comprehensive control through continuous monitoring and immediate detection. This way, you can significantly reduce the resources required for manual checks.

Proactive Threat Management

Proactive Threat Management

Leverage ONEKEY’s cutting-edge threat detection to identify and address cyber risks early, enhancing the reliability and functionality of your devices. Gain peace of mind with ONEKEY’s advanced features for Zero-Day vulnerability detection.

Integrated SBOM Management

Integrated SBOM Management

ONEKEY consolidates SBOM management, regulatory compliance, and cybersecurity into one unified platform. Ensure consistency, efficiency and a seamless experience across all your teams and your entire product portfolio.

Care for Product Cybersecurity and Compliance?

Meet the automated vulnerability platform taking your solutions from concept to market, fast and secure. At scale.

onekey users

Why Customers Trust Us

ATOS

“ONEKEY helps us to uncover critical vulnerabilities in embedded devices in a fully automated way. This allows us to target manual testing efforts more efficiently on business logic issues.“

Wolfgang Baumgartner
Wolfgang Baumgartner
Head of Global Security Consulting at Atos
snap one

“ONEKEY’s automated binary software analysis simplifies product security at Snap One by reducing manual efforts while increasing transparency and confidence. We enjoyed a smooth onboarding experience and highly recommend the excellent support from a team of experts.”

Connie Gray
Connie Gray
Sr. Director of Engineering, Cybersecurity & Product Security at Snap One
swisscom

“We use ONEKEY to check every piece of software for potential risks before it even reaches release candidate status, at which point any issues are immediately analyzed and fixed. This allows us to effectively secure new features and interfaces.”

Giulio Grazzi
Giulio Grazzi
Senior Security Consultant at Swisscom.
kudelski

“We provide best-in-class services to our IoT customers, helping them ensure security throughout their entire product lifecycle. So naturally we want to deliver continuous firmware monitoring and vulnerability assessments using the best tools and solutions in the business. ONEKEY's automated firmware analyses help us to deliver our services efficiently and with unparalleled quality.“

Joël Conus
Joël Conus
First Vice President IoT R&D and Services at Kudelski IoT
Trimble

“ONEKEY’s capabilities and security expertise made it a truly eye-opening experience to work with them.”

Nigel Hanson
Nigel Hanson
AppSec + Hardware Security Specialist at Trimble
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Seamless Integration with Your Workflow

Streamline your cybersecurity workflow and achieve regulatory compliance with ONEKEY's end-to-end platform.

Azure Entra ID

Enable SSO with any identity provider supporting OpenID connect

Jenkins

Integrate an automatic quality gate within your CI/CD pipeline orchestration tools

Splunk

Automate threat detection and ticket creation via SIEM tools

Power BI

Share relevant data with dashboard and KPI tools for your stakeholders

Jira

Create tickets within ticketing, project management and productivity tools

Icon of a plus button

GitLab, GitHub, Bitbucket & more

Upload firmware and query results with DevOps tools

More Features for Modern Risk Management

Meet our purpose-built platform to save you money, time and resources.

Save Time Triaging Your CVEs
Automated Impact Assessment

Save Time Triaging Your CVEs

Streamline vulnerability management with automated scans and impact assessments. Focus on critical risks and mitigate them with recommended strategies.

Ensure Security with Continuous Scans
Monitoring

Ensure Security with Continuous Scans

ONEKEY re-analyzes your firmware daily, updating vulnerabilities and providing alerts to keep your firmware secure.

Avoid Open-Source Licensing Issues
Open Source License Detection

Avoid Open-Source Licensing Issues

Streamline open-source license management. Simplify validation, minimize risks, automate audits, and maintain accurate records.

FAQs

Get detailed answers to the most common questions on safeguarding your connected products.

onekey users

What is Product Cybersecurity?

Product cybersecurity ensures your digital products—whether software, hardware, or connected devices—are protected against cyber threats throughout their entire lifecycle. From design to deployment and beyond, robust cybersecurity practices safeguard against data breaches, unauthorized access, and cyberattacks. This proactive approach not only secures the product but also ensures compliance with evolving regulations, reducing risks and maintaining the integrity and trustworthiness of your technology.

Why is Product Cybersecurity Important?

Product cybersecurity is essential to protect your digital products from cyber threats, safeguarding sensitive data and ensuring seamless operation. Without it, your products and users are at risk of attacks, data breaches, and unauthorized access that can result in costly financial losses, reputational damage, and compromised safety. Strong cybersecurity practices help you stay compliant with regulations, build customer trust, and keep your products resilient against evolving cyber threats.

How do you ensure product cybersecurity?

Securing your products requires a strategic and continuous approach throughout their entire lifecycle. Here’s how you can achieve it:

  • Conduct Security Audits & Assessments: Regularly evaluate your products to uncover and fix vulnerabilities before they become threats.
  • Manage Vulnerabilities Effectively: Leverage SBOMs, VEX, and automated tools to track, assess, and mitigate risks.
  • Stay Updated: Keep your products secure by applying patches and updates to defend against the latest cyber threats.
  • Ensure Compliance: Meet all relevant security standards and regulations to avoid legal risks and maintain customer trust.

Build. Comply. Resist. Repeat. With these steps, you’ll stay ahead of the curve and keep your products and customers secure.

What is an SBOM used for?

An SBOM (Software Bill of Materials) gives you a complete overview of all components in your software. It’s key for managing vulnerabilities, sharing information, ensuring license compliance, and maintaining transparency across your supply chain. With an SBOM, you gain the visibility you need to keep your products secure and compliant—every step of the way.

What is a Digital Cyber Twin?

A Digital Cyber Twin is a virtual replica of your product’s digital ecosystem. It lets you test and analyze your system in a safe, simulated environment—detecting vulnerabilities and optimizing security before they can impact your real-world product. It’s like having a crystal ball for your cybersecurity, helping you stay ahead of potential threats without risking your actual systems.

Get Started Fast

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Step 1

Talk to an expert for an initial assessment.

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Step 2

Benefit from a personalized demo with real data.

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Step 3

Receive a quote with all your requirements to start.

Tanja Sommer onekey
Tanja Sommer
tanja.sommer@onekey.com

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