#USA #Campbell #Enlil #Voler Systems #Aquillius Innovation

Enlil's Strategic Partnerships to Propel MedTech Innovation

Enlil, Inc., part of the Shifamed portfolio, has recently made headlines with its announcement of seven strategic partnerships formed within 2025. As a leader in MedTech product innovation, these collaborations represent a significant step forward in addressing the multiple challenges faced by companies in the medical device development ecosystem. The agreements encompass referral, reseller, deployment, and regulatory consultation partnerships, enhancing Enlil’s capabilities and range of offerings in the sector.

Nader Fathi, CEO of Enlil, expressed pride in these developments, stating, "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." This comprehensive strategy seeks to support a faster path to FDA clearance while ensuring improved patient outcomes through ongoing innovation.

Collaborative Efforts with Leading Organizations

Some of the new alliance partners include notable names such as:

• - Voler Systems (Sunnyvale, CA)
• - Aquillius Innovation Hub (San Diego, CA)
• - AVS Life Sciences (Pottstown, PA)

Miguel Adao, President and CEO of Voler Systems, emphasized the importance of seamless collaboration among MedTech OEMs and their partners. He stated, “The Enlil Development Traceability platform is an essential bridge between these teams, enabling true collaboration, traceability, and efficient documentation management across the product lifecycle.” This collaborative sentiment underscores the necessity for modern innovators in the MedTech space to work in alignment, sharing data effectively to navigate the complexities of regulatory environments.

Strengthening Regulatory Support for MedTech Startups

Alongside the innovation partnerships, Enlil has also announced collaborations with four regulatory consulting firms, which significantly bolster support for MedTech startups. The partners include:

• - Quality System Consultants (Santa Clara, CA)
• - BayCath Medical (Mountain View, CA)
• - Rook Quality Systems (Dunwoody, GA)
• - Aetherium Regulatory Consulting (ARC) (Newark, DE)

Kyle Rose, Founder and CEO of Rook Quality Systems, provided insight into the challenges faced by MedTech teams. He explained, “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.” However, with Enlil’s connectivity across the development journey—from design control to inventory management—these hurdles can be effectively overcome, creating a cohesive and auditable traceability story.

Driving Adoption of Enlil’s AI Platforms

The advent of these partnerships is poised to significantly drive the adoption of Enlil’s AI-assisted development traceability platform within the MedTech industry. By aligning with leaders in regulatory consultancies and innovation support, Enlil aims to sharpen its service offerings while expanding its reach. This collaborative approach enhances end-to-end traceability, increases implementation speed, and allows for deeper integration throughout product development.

Fathi further commented, “Our shared mission is to simplify the path to FDA clearance and enable better patient outcomes through innovation.” He highlighted that the expertise these new partners bring to the table serves as crucial support for delivering rapid, intelligent, and scalable solutions that meet tomorrow's healthcare demands.

Enlil's Vision for the Future

As a proud member of the Shifamed portfolio, Enlil is dedicated to redefining how innovative MedTech companies bring life-changing technologies to market. Their cloud-based platform is tailored for teams engaging with nuanced regulatory pathways, merging design control, quality management, compliance, and development tools, enhanced by the capabilities of AI. This innovative approach provides a streamlined pathway to FDA clearance through intelligent traceability, audit readiness, and comprehensive process integration.

For those interested in learning more about how Enlil is transforming medical device development, further information is available at enlil.com.

Media Contact

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