Summary: Interlynk’s selection by a global MDM underscores the importance of SBOM solutions in achieving FDA cybersecurity compliance. Its SBOM Automation Platform helps healthcare organizations manage software risks, maintain transparency, and meet evolving FDA guidelines, enabling early adopters to gain competitive advantages and ensure product safety and regulatory readiness.

Key Takeaways:

  • Interlynk’s SBOM solutions empower medical device manufacturers to meet stringent FDA cybersecurity and compliance mandates.
  • Early adopters of SBOM practices in the medical device sector can improve product safety, regulatory readiness, and gain a competitive edge in the market.

Interlynk, a provider of SBOM automation and software supply chain security, announced that it has been selected by a large global medical device manufacturer (MDM) for FDA cybersecurity compliance. According to the company, this collaboration highlights Interlynk’s growing influence in the medical device sector, where regulatory frameworks and cybersecurity needs are driving innovation and compliance.

Regulatory Framework and Compliance Milestone

The partnership marks a significant milestone for Interlynk, which continues to support MDMs in complying with the FDA’s cybersecurity guidelines under Section 524B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). These regulations mandate that medical devices include Software Bills of Materials (SBOMs) to ensure transparency, traceability, and risk management across their software components.

Interlynk also announced that, since its September debut, the free tier of its SBOM Automation Platform has been adopted by over 50 organizations worldwide.

“This partnership with a global leader in medical devices reinforces Interlynk’s leadership in SBOM management and our ability to adapt to the unique challenges faced by highly regulated industries like healthcare,” said Ritesh Noronha, CTO of Interlynk. “Reaching 50 organizations on our platform in less than three months is a testament to the value of our solutions for companies of all sizes, enabling them to meet regulatory requirements while improving software transparency and security.”

Competitive Edge through SBOM Practices

As regulatory pressures intensify, early adopters of SBOM practices in the medical device sector can gain a competitive edge in product safety, compliance, and market readiness, according to the company. Interlynk’s SBOM Automation Platform delivers key benefits to medical device manufacturers, including:

  • Enhanced Cybersecurity: Interlynk helps identify and mitigate vulnerabilities, outdated and deprecated components, and malicious components from infecting devices.
  • Software Supply Chain Security: Interlynk ensures supplier components meet regulatory standards and facilitates collaborative risk management.
  • FDA 510(k) Compliance: Interlynk supports premarket and postmarket requirements for SBOM submission, vulnerability management, and continuous monitoring.
  • Operational Efficiency: Interlynk automates compliance workflows, cutting costs and improving internal and regulatory reporting traceability.

The FDA’s oversight of medical device cybersecurity emphasizes the importance of SBOMs in managing risks associated with third-party and open-source software components. Interlynk’s platform equips MDMs with the tools to maintain accurate software inventories, implement effective vulnerability management, and comply with evolving regulatory requirements.