Enlil and Interlynk Partner to Close the Cybersecurity Gap for SaMD and Connected Medical Devices

Integrated platforms enable MedTech leaders to meet FDA cybersecurity expectations by design, uniting SBOM management, vulnerability monitoring, AI model traceability, and regulatory traceability.

CAMPBELL, Calif., Jan. 28, 2026 /PRNewswire/ -- Enlil, Inc., the unified product lifecycle traceability platform for medical device innovators, today announced a strategic partnership with Interlynk, Inc., an enterprise product security platform specializing in software and AI supply chain cybersecurity. Together, they're delivering an integrated solution that embeds cybersecurity compliance and traceability for Software-as-a-Medical Device (SaMD) developers and medical device manufacturers.

As regulators raise the bar on cybersecurity transparency and post-market risk management, medical device teams face a growing challenge: an accurate Software Bill of Materials (SBOM) is foundational, but it is only the starting point.

What's missing is continuous insight into software vulnerabilities, threat exposure, AI model integrity, and validation of readiness across the product lifecycle. The Enlil–Interlynk partnership directly addresses this gap.

Why This Partnership Matters Now

Cybersecurity is now central to patient safety and market success. FDA Refuse to Accept (RTA) policies, EU MDR expectations, and regulatory initiatives increasingly demand manufacturers demonstrate software transparency and continuous cybersecurity risk management throughout their products' lifecycle.

SBOMs, comprehensive lists of software components, are essential, but without automated monitoring, clear context, and connection to the product lifecycle, they risk becoming static artifacts rather than useful tools for day-to-day operations.

"SBOMs shouldn't live as static documents created just to pass a submission gate," said Surendra Pathak, CEO of Interlynk. "By partnering with Enlil, we're turning SBOMs into living, actionable intelligence, helping device teams continuously understand risk, respond faster, and stand up to regulatory scrutiny throughout the product lifecycle."

A Unified Approach to Cybersecurity, Quality, and Regulatory Readiness

Through this partnership, Enlil's cloud-native product lifecycle and traceability platform integrates with Interlynk's SBOM-, VEX-, and AI-BOM-powered cybersecurity solutions, giving MedTech teams a single, connected view of:

• The software and AI components that are built into the product.
• The vulnerabilities and exposures that matter.
• How risks are assessed, mitigated, validated, and documented.
• How evidence remains continuously audit-ready.
• Identified open-source components (publicly available software) and their dependencies, posing a risk to the overall product.
• The software product revisions impacted by threats and vulnerabilities, and downstream manufacturing lots and shipments that are affected.

For SaMD and AI-enabled medical devices, the integrated solution also supports emerging FDA expectations around training data provenance, data integrity, and AI model supply chain security.

This includes traceability of training, validation, and test datasets; protection against unauthorized modification or data poisoning; and version-controlled, cryptographically verifiable AI models treated as regulated software artifacts.

With Interlynk's AI Bill of Materials (AIBOM, a list of all components in an AI solution), teams can track AI models, datasets (collections of related data), and dependencies using the same SBOM-driven infrastructure, extending cybersecurity and regulatory rigor seamlessly into AI-powered systems.

The integrated solution delivers a shift-left approach to cybersecurity, enabling executive teams to proactively embed security, quality, and compliance from early development to post-market. When issues arise, leadership will have the tools for rapid containment, focused remediation, and immediate control over impacted assets.

"For modern medical devices, software risk is product risk," said Charu Roy, Chief Product Officer at Enlil. "This partnership brings cybersecurity directly into the product lifecycle, so teams can manage software and AI risk with the same rigor as quality and regulatory requirements, from design through post-market."

Key Benefits for SaMD and Software-Driven Medical Devices

Cybersecurity Built In—Not Bolted On
Embed SBOM, AIBOM, and vulnerability intelligence early to reduce remediation and regulatory challenges.

Automated, Living Bills of Materials
Generate and maintain machine-readable SBOMs and AIBOMs using industry formats like CycloneDX and SPDX. These documents provide ongoing monitoring and actionable context for software and AI components.

End-to-End Traceability
Link cybersecurity risks, mitigation efforts, verification activities, and regulatory evidence directly within Enlil's unified single source for tracking all product data.

Always-On Regulatory Readiness
Stay aligned with evolving FDA cybersecurity guidance and global requirements through structured workflows, audit trails, and real-time visibility.

Meet Enlil and Interlynk at MD&M West 2026

Medical device manufacturers and SaMD developers can see the integrated Enlil–Interlynk solution live at MD&M West, February 3–5, 2026, in Anaheim, California, at the Enlil Booth #1090.

Attendees are invited to learn how Enlil and Interlynk are helping teams:

• Move beyond checkbox SBOMs.
• Operationalize cybersecurity and AI governance across the product lifecycle.
• Prepare for FDA and global cybersecurity scrutiny before it becomes a market blocker.

About Enlil, Inc.

Enlil is a cloud-native development traceability platform built for medical device and life sciences organizations. Designed to support regulatory readiness across the product lifecycle, Enlil connects quality, regulatory, R&D, manufacturing, and operations teams around a unified system of record.

By structuring data for traceability, auditability, and real-time visibility, Enlil helps MedTech innovators manage complexity, maintain inspection readiness, and scale compliance from concept through commercialization.

Learn more at enlil.com.

About Interlynk, Inc.

Interlynk is an enterprise product security platform that helps organizations build, secure, and maintain regulatory-compliant software and AI products at scale.

Interlynk enables teams to generate, manage, and analyze Software, AI, and Cryptographic Bills of Materials (SBOM, AIBOM, and CBOM), providing continuous visibility into product and AI dependencies, third-party risk, and software supply chain exposure.

Designed for security, engineering, and compliance teams, Interlynk simplifies adherence to global regulatory requirements while improving operational efficiency. It delivers the trust, transparency, and control enterprises need to secure their digital products.

Learn more at interlynk.io.

MEDIA CONTACT
Sandra Schwartzman
RMR & Associates
(201) 704 – 8583
sschwartzman@rmr.com

SOURCE Enlil, Inc.