The all-in-one, cloud-native solution integrates AI-powered intelligence to transform how OEMs and contract manufacturers manage development, ensure compliance, and accelerate time-to-market.

 Enlil, Inc., a Shifamed portfolio company accelerating innovation for regulated products with its comprehensive development traceability platform, announced growing momentum across the global MedTech innovation ecosystem. Since the February appointment of seasoned technology leader Nader Fathi as CEO, Enlil has significantly expanded its reach among OEMs, contract manufacturers, and industry partners. With over 600 users worldwide, Enlil is revolutionizing how the MedTech innovation ecosystem can streamline the path to commercialization through the digital acceleration of product development, compliance, and regulatory readiness.

At the core of Enlil’s offering is its use of AI-powered intelligence, including a private large language model (LLM)–driven chatbot. By embedding secure, contextual AI into its platform, Enlil’s chatbot Ask Lily extracts insights with unprecedented speed and accuracy, empowering engineering, quality, and regulatory teams to make smarter decisions without compromising sensitive IP or compliance integrity.

Enlil revolutionizes how the MedTech innovation ecosystem brings regulatory ready, breakthrough devices to market faster

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Purpose-built to overcome the challenges of fragmented technology stacks and siloed documentation, Enlil’s platform enables end-to-end traceability, secure cross-functional collaboration, and regulatory agility from ideation to post-market surveillance. The platform integrates key product development disciplines—Requirements Management, QMS, PLM, Manufacturing, ERP, Regulatory Compliance, and Post-Market Surveillance—into a unified digital thread, allowing distributed teams to work together in real-time.

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“Today’s MedTech ecosystem demands more than legacy tools patched together—it needs a platform designed for regulatory complexity, distributed collaboration, and speed,” said Nader Fathi, CEO of Enlil. “Enlil bridges the gap between iteration and regulation, empowering teams to bring breakthrough devices to market faster and more confidently.”

Uniquely, Enlil’s development traceability platform:

  • Leverages private AI to accelerate regulatory workflows: Features like AI-driven insights and real-time change control help teams stay ahead of compliance requirements, making the process less burdensome.
  • Supports complex development relationships: Facilitates seamless collaboration across innovation hubs, contract manufacturers, and OEMs, regardless of geography.
  • Manages diverse product types: Enlil supports MedTech hardware, Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), diagnostics, high tech, and more.

Built with geographically diverse teams in mind, Enlil empowers OEMs and contract manufacturers to streamline documentation, enhance visibility, and reduce regulatory friction at every development milestone.

“MedTech companies increasingly understand that generic, retrofitted solutions from other industries are inadequate for their unique regulatory demands,” added Fathi. “We engineered Enlil from the ground up to meet the complexity of MedTech compliance. That is why our platform is rapidly becoming the go-to system for organizations serious about accelerating safe, high-quality innovation.”

Enlil is investing in talent and partnerships to meet growing demand as it expands its global presence. Backed by advanced AI capabilities and the strength of the Shifamed innovation network, Enlil is establishing itself as the leading platform for regulated product development.

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Source – PR Newswire