Enlil Announces Seven Strategic Partnerships To Accelerate Medtech Innovation And Customer FDA Clearance Success

(MENAFN- PR Newswire) "We are proud to have gained the trust of some of the most respected organizations in MedTech services, who recognize our AI-powered, purpose-built platform as a solution to persistent challenges in regulated development," said Nader Fathi, CEO of Enlil. "These dynamic collaborations not only broaden our impact but also provide vital insights that help guide our continuous innovation."

Our shared mission is to simplify the path to FDA clearance and enable better patient outcomes through innovation.

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New Alliance Partners

Enlil has forged alliance agreements with three highly regarded organizations known for empowering MedTech innovation:

• Voler Systems (Sunnyvale, Calif.)
• Aquillius Innovation Hub (San Diego, Calif.)
• AVS Life Sciences (Pottstown, Pa.)

"At Voler, we see how critical it is for MedTech OEMs and their contract partners to work seamlessly together - sharing data, documentation, and managing risk in a highly regulated environment," Miguel Adao , President and CEO of Voler Systems, remarked. "The Enlil Development Traceability platform is an essential bridge between these teams, enabling true collaboration, traceability, and efficient documentation management across the product lifecycle. It is precisely the kind of solution today's innovators need to succeed."

New Regulatory Consulting Partners

Enlil also announced collaborations with four regulatory consulting firms, deepening support for MedTech startups seeking FDA clearance, deployment resources, and managing post-market operations:

• Quality System Consultants (Santa Clara, Calif.)
• BayCath Medical (Mountain View, Calif.)
• Rook Quality Systems (Dunwoody, Ga.)
• Aetherium Regulatory Consulting (ARC) (Newark, Del.)

"Too often, MedTech teams are stuck with siloed document control or QMS tools that can't tell the full audit story regulators want to see," explained Kyle Rose , Founder and CEO of Rook Quality Systems. "What sets Enlil apart is its ability to connect every part of the development journey, design controls, risk management, inventory, and documentation into one complete, auditable traceability story from concept through FDA clearance and beyond. That's a game-changer for our clients."

Partnerships Drive Adoption of Enlil's AI Platform

The new partnerships mark a significant step forward in expanding the MedTech industry's adoption of Enlil's agentic AI-assisted development traceability platform. By aligning with leaders in regulatory consulting and innovation support, Enlil enhances both its service reach and sharpens its ability to deliver end-to-end traceability, faster implementation timelines, and deeper integration across the product development lifecycle. Together, these partners help accelerate time to market while reinforcing compliance rigor.

"Our shared mission is to simplify the path to FDA clearance and enable better patient outcomes through innovation," emphasized Nader Fathi. "These new partners bring critical expertise that helps us deliver faster, smarter, and more scalable solutions to the teams building tomorrow's devices."

About Enlil

A proud Shifamed portfolio company, Enlil is redefining how innovative MedTech companies bring life-changing technologies to market. Purpose-built for dynamic 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. Learn more by visiting enlil .

MEDIA CONTACT
Sandra Schwartzman
RMR & Associates
(301) 230 – 0045 x 100
[email protected]

SOURCE Enlil, Inc.

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