Interlynk Inc. Supports FDA Cybersecurity Compliance for BIOTRONIK
REDWOOD CITY, Calif., August 06, 2024 – Interlynk Inc., a provider of Software Bills of Material (SBOM) products and services, has been selected by a leading global medical products company, BIOTRONIK, to support compliance with FDA-mandated cybersecurity requirements. This partnership aims to safeguard BIOTRONIK's medical devices that improve the lives of millions suffering from heart and blood vessel diseases and chronic pain.
The Importance of SBOM in Medical Devices
The U.S. Food and Drug Administration (FDA) recently released new guidelines emphasizing the significance of SBOM to ensure medical devices remain safe from cyber threats. An SBOM is a detailed list of all software components used in a device, serving as a crucial tool for identifying vulnerabilities and ensuring cybersecurity compliance.
Interlynk's SBOM Platform offers a Software as a Service (SaaS) solution to help meet these compliance requirements, in addition to similar mandates from the Cyber Resilience Act (CRA) and the White House’s Executive Order 14028 on Cybersecurity. The platform enables clients to assess risks associated with third-party software, automate SBOM generation, and monitor open-source license risks and the health of open-source components.
Comprehensive Services for Compliance and Security
Interlynk's services include SBOM generation, vulnerability reporting, and open-source risk assessment. These services will help BIOTRONIK ensure their products remain secure and compliant with stringent FDA cybersecurity standards. Furthermore, Interlynk's SBOM Program as a Service provides guidance on building an SBOM program and a roadmap to deploy SBOM for compliance with third-party risk evaluations.
Statements from Leadership
Ritesh Noronha, Co-Founder and CTO of Interlynk, expressed gratitude for the partnership, saying, "We are pleased and grateful that BIOTRONIK chose Interlynk to support the implementation of their vigorous cybersecurity processes. We are confident that our SBOM Platform and suite of related services will meet and exceed BIOTRONIK’s cybersecurity and open-source monitoring needs."
Alan Fryer, Director of Global Product Cybersecurity at BIOTRONIK, added, "BIOTRONIK’s commitment to excellence and high-quality standards is unwavering. Our choice to partner with Interlynk is a testament to this commitment. Interlynk’s robust tools enable us to manage SBOMs effectively and expedite the discovery and management of potential cybersecurity vulnerabilities. This strategic partnership strengthens our ability to safeguard our products and, most importantly, our patients."
About Interlynk Inc.
Founded in 2022 and headquartered in Redwood City, Calif., Interlynk Inc. provides SBOM- and VEX-powered platforms that automate and continuously monitor first-party and vendor software supply chains, helping to meet FDA, CRA, GSA, DoD, and other compliance obligations. Interlynk was founded by technology leaders Surendra Pathak and Ritesh Noronha, who have proven experience building complex, data-intensive applications and leading teams to significant exits.
About BIOTRONIK
At BIOTRONIK, patient well-being has been our top priority for more than 60 years. As a leading global medical technology company, we provide products and services that save and improve the lives of millions suffering from heart and blood vessel diseases and chronic pain. Driven by our purpose to perfectly match technology with the human body, we develop trusted cardiovascular, endovascular, and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in more than 100 countries.
