Develop Better Products Faster

Modern SaaS solution allows medical device companies to track data required to successfully achieve key milestones.

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Enlil Inc.

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Enlil Inc. forms digital threads through User Needs, Requirements, Test Cases, Standards as well as links to Software & Hardware versions, Engineering Builds and ultimately Lot History Records. All of this data forms the backbone to achieving milestones in the journey of a Device.

Solutions

Trace and Risk

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Our end-to-end solution traces design and test artifacts, streamlines decision-making, and brings products to market faster. Enlil offers customers guidance and an easy way to track and trace Requirements or Test Cases to important enterprise data such as Standards, Software code versioning systems, Engineering Builds, Quality Specs.

Design to Make

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Enlil offers a Part 11 compliant cloud solution which allows users to track all crucial data during early product development. From auditing and approving documents, data and process to Parts, Equipment, Designs, Process, Enlil provides a seamless experience finding and linking all data needed to provide IP and get ready for Audits

Data to Insights

Make data-driven decisions and streamline innovation with Enlil’s powerful automation tools

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Co-pilot for Product Development
Enlil revolutionizes how devices are developed by providing a modern copilot cloud based service. Our comprehensive solution goes beyond traditional document control and quality management, providing a centralized platform for tracking standards, software and hardware dependencies together in one system.
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Traceability for regulatory submissions
Enlil ensures comprehensive traceability across diverse data sources for Product Designs. Our system seamlessly traces crucial information from User Needs to Requirements to Test Cases, to Engineering Builds and Lot History Records and Testing Evidence. We provide regulatory services to meet deadlines and milestones with the FDA and maintain the trace matrix for the product.
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Audit and FDA Compliance Readiness
Enlil provides a robust framework for audit readiness and FDA compliance. Be prepared for inspections with design templates and pre-submission support. Simplify regulatory compliance to save time and effort.
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Collaboration and Document Control
Enable teamwork with Enlil's information sharing and document control across multi-disciplinary teams. Ensure easy access, version control, e-Signatures and approval workflows for critical regulatory documentation. One single source of truth for all your teams.
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Product Performance Insights
View operational metrics into product and processes, for continuous quality improvement and coordination.
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What our customers say about us

“Organization is extremely important as a purchaser for multiple companies, and Enlil provides me with all the tools I need to easily maintain the structure required to assist in my day-to-day tasks. I can work seamlessly within the system with the faith in knowing my records and documents are safe, secure, and painless for me or other users to search for if need be. It really is my one stop shop for all my purchasing and receiving needs.”
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Brittany Kromer
Purchasing & Materials Specialist - Shifamed
“I have been transitioning all our manufacturing documentation into Enlil for the past several months. The Enlil team has added features and improved the eLHR UI design to support my endeavor. Whenever I’ve encountered, or caused, any issues the team was quick to respond and provide a thorough fix. I highly recommend Enlil to anyone seeking a reliable and user-friendly solution, backed by outstanding customer support.”
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Mike Heck
Process Development - Myra Vision
“The team at Myra Vision has been using a variety of the modules within Enlil – Document Control, Supplier Management, Purchase Orders, Training, etc. – for over two years now. While the Enlil team will be the first to say there is much work left to do, I’ve observed a pattern of continuous improvement that addresses key functions systematically. The team has also been receptive to issues raised by Enlil users and executes practical solutions quickly and effectively. I look forward to the development projects on the horizon that will optimize the routine use of the system, helping to ensure compliance and faster delivery of life-enhancing products to our customers.”
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James Papasin
Director of Quality Assurance - Myra Vision

Meet Our Leadership