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Company's unified platform will now connect finance, design, and manufacturing in one regulatory-ready environment.
November 5, 2025
By: Michael Barbella
Managing Editor
Enlil Inc. has announced new associations with Bill.com, PTC Onshape, and Dassault Systèmes SolidWorks. As part of Enlil’s unified platform spanning the entire medical device development lifecycle, these integrations aim to bring seamless financial and mechanical CAD (mCAD) connectivity into its regulatory-ready environment.
The collaboration with Bill.com enables Enlil users to automate financial workflows as part of a unified lifecycle platform. Benefits include:
For product design and engineering, Enlil’s integrations with Onshape and SolidWorks establish the platform as the single source of truth across development. Event-driven CAD-to-Enlil synchronization eliminates manual data re-entry, with the latest design data instantly accessible across engineering, quality, manufacturing, and supply chain functions. Benefits include:
Unlike generic CAD connectors, Enlil builds integration into third-party platforms with medtech regulatory requirements at the core. By linking CAD design data, BOMs, and engineering change records directly into Enlil, companies can automatically compile the evidence needed for U.S. Food and Drug Administration (FDA) submissions, including design history file, device master record, and device history record. This automation reduces manual effort, mitigates the risk of rejected submissions, and helps companies avoid costly time-to-market delays due to remediation or resubmissions.
“Enlil unifies medtech innovation, quality, and compliance in a way that scales with customer needs,” Enlil CEO Nader Fathi said. “With Bill.com, Onshape, and SolidWorks integrations, Enlil delivers bi-directional connections that eliminate errors, accelerate time to market, and streamline regulatory readiness—creating a single source of truth.”
A Shifamed portfolio company, Enlil is redefining the ways in which innovative medtech companies bring life-changing technologies to market. Purpose-built for teams navigating complex regulatory pathways, Enlil’s cloud-based platform combines design control, quality management, compliance, and development tools with agentic AI capabilities, providing a fast track to FDA clearance through intelligent traceability, audit readiness, and end-to-end process integration.
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