Summary: Interlynk Inc. will support BIOTRONIK in meeting FDA cybersecurity requirements by providing Software Bill of Materials (SBOM) generation, vulnerability reporting, and open-source risk assessment for its medical devices.

Key Takeaways:

  • Partnership Announcement: BIOTRONIK has chosen Interlynk Inc. for SBOM-related services to comply with FDA cybersecurity requirements.
  • Service Provision: Interlynk will offer SBOM generation, vulnerability reporting, and open-source risk assessment for BIOTRONIK’s products.

Interlynk Inc., which provides Software Bills of Material (SBOM) products and services to medical device manufacturers and independent software vendors, announced that it has been selected by BIOTRONIK to support compliance with FDA-mandated cybersecurity requirements.

Service Details

Under the arrangement, Interlynk will provide BIOTRONIK with SBOM generation, vulnerability reporting, and open-source risk assessment across its products for people suffering from heart and blood vessel diseases as well as chronic pain.

FDA and Cybersecurity Compliance

The U.S. Food and Drug Administration recently released new guidelines that underscore the importance of SBOM to ensure that medical devices remain safe from cyber threats. The Interlynk SBOM Platform delivers Software as a Service (SaaS) to help meet these compliance requirements in addition to similar requirements stemming from the Cyber Resilience Act (CRA) and the White House’s Executive Order 14028 on Cybersecurity. The platform also allows clients to evaluate risks associated with third-party software; connects software build pipelines for automated SBOM generation; automates SBOM collection through the software supply chain; and monitors open-source license risks as well as the health of open-source components including risk scores, reputation, maintainability, and country of origin.

SBOM Program and Benefits

Interlynk also offers an SBOM Program as a Service to provide guidance in building an SBOM program and a roadmap to deploy SBOM to meet compliance requirements of third-party risk evaluation. Interlynk’s SBOM product and services help medical device manufacturers meet stringent cybersecurity requirements and open-source monitoring, and its product helps independent software vendors secure their software supply chains and meet customer-specific SBOM requirements.

“We are pleased and grateful that BIOTRONIK chose Interlynk to support the implementation of their vigorous cybersecurity processes,” said Ritesh Noronha, co-founder and CTO of Interlynk. “We are confident that our SBOM Platform and suite of related services will meet and exceed BIOTRONIK’s cybersecurity and open-source monitoring needs.”