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Smart, Reliable and Secure Solutions
for Medical Devices

Life-critical reliability. FDA compliance. Secure, interconnected, machine-to-machine (M2M) embedded systems. Real-time performance. Remote access and multi-dimension user interfaces. IoT. These are just some of the benefits and use cases Timesys addresses with its medical customers.

security for medical devices;

Smart, Reliable and Secure Solutions
for Medical Devices

Life-critical reliability. FDA compliance. Secure, interconnected, machine-to-machine (M2M) embedded systems. Real-time performance. Remote access and multi-dimension user interfaces. IoT. These are just some of the benefits and use cases Timesys addresses with its medical customers.

Timesys Vigiles can help you ensure your medical devices are more secure when they are released and maintain stronger security during deployment

Timesys Vigiles security vulnerability SBOM scanner

Industry’s only SCA tools optimized for embedded open source, including Yocto, Buildroot, and Timesys Factory Linux, and open source package monitoring

Boosts security standard compliance: IEC 62304, FDA Premarket and Postmarket Security Guidance

Filter, triage, investigate and mitigate vulnerabilities based on your exact Software Bill of Materials (SBOM)

Medical device security is critical. A successful cybersecurity attack can put patients at risk, compromise health care outcomes and violate privacy laws.

Gone are the days when you could freeze your software at release and never touch it again. Device connectivity is now the norm, and hundreds of new vulnerabilities are uncovered every week, putting devices and customers at risk of compromise.

Timesys Vigiles is a Software Composition Analysis (SCA) and Linux/open source software vulnerability monitoring tool for embedded system security. Vigiles offers multiple security maintenance features that simplify compliance with the FDA’s cybersecurity guidance for medical devices. With Vigiles, your products will be more secure at release and stay secure throughout the lifecycle.

To learn how Timesys’ Vigiles Security Vulnerability Monitoring & Management can help you streamline FDA Security Guidance Compliance, read our Medical Device Security Solution Note. To start tracking and filtering vulnerabilities for your medical device, get started using Vigiles for free today.

See how Timesys has helped customers building medical devices successfully bring products to market faster, with higher quality, and with stronger security

Case Study: Medical device maker maintains strong product security with Timesys

A leading manufacturer of medical devices wanted to ensure its product line, which featured an NXP i.MX 6 processor based Advantech Qseven module, was kept updated, in sync and secure throughout its development and release. See how Timesys helped the company efficiently manage its product software security and updates throughout the product lifecycle.
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Timesys provides solutions to the “Top 30” medical device makers, helping them build FDA Class I, II, and III devices for a broad array of medical needs. Timesys’ Software Engineering Services excel in addressing remote mobile access, networked devices, and integrated systems — from the BSP to the App and UI. Furthermore, Timesys’ Development Environment both directly and indirectly supports FDA certification requirements, which include: build repeatability, documentation, source origin, test reports based on automated regression testing, ongoing security vulnerability notification and patches, and OS maintenance.

Completed Projects

  • Imaging: CT/PET/X-Ray Instrumentation
  • Therapeutics: Infusion Pumps, Surgery Devices, etc.
  • Biotech and Life Sciences: DNA sequencing, Genetic Analysis
  • Diagnostics: Cardiology, Hematology, Immunoassay, Analyzers

Areas of Expertise

  • Software and BSP development respecting the medical market standards (vulnerability analysis, review of the development process, etc.)
  • Secure connectivity between devices (WiFi, BT, RFID, NFC, etc.)
  • Cross-platform, custom, embedded and mobile applications integration (native technologies in C/C ++, Qt, HTML5, Node.js, Django, Java, Microsoft.NET)
  • Security — BSP hardening, vulnerability notification and patching, secure boot, firmware upgrade
  • Full BSP integration and optimization, hardware/software compatibility, and middleware validation testing

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