Amend Surgical Proudly Announces ISO 13485 Certification, Advancing Toward Launch of Amend Tissue Tape™

ALACHUA, Fla., Jan. 26, 2026 /PRNewswire/ -- Amend Surgical, a medical device company focused on novel products for oral wound-care and regenerative biomaterials, today announced that it has achieved ISO 13485:2016 certification, the global standard for medical device quality management systems.

The achievement of ISO 38485:2016 certification underscores Amend Surgical's commitment to safety, regulatory compliance, and operational excellence, confirming that the company maintains robust, auditable processes for the design, development, and manufacture of its NanoFUSE™ bone graft technologies. This milestone further strengthens the company's manufacturing readiness as they advance their pipeline of next generation oral surgery solutions including the launch of Amend Tissue Tape™ and NanoFUSE™ for dental applications later this year.

"This is an important milestone for Amend," said Robby Lane, CEO and Co-Founder, "Achieving ISO 13485 certification validates the strength of our quality systems and establishes a critical foundation for the next stage of our growth. As we move toward the anticipated regulatory clearance for Amend Tissue Tape™ in 2026, this certification ensures that we meet the highest global standards for safety and performance." 

The certification follows a comprehensive evaluation of Amend Surgical's quality management system, including design controls, supplier management, process validation, documentation, risk management, and post-market surveillance. The achievement positions the company to scale efficiently and enhance manufacturing capabilities for both proprietary and partner products.

Providing our customers with safe, high-quality medical devices has always been our top priority," said Carol Muniz, Director of Quality Assurance. "ISO 13485:2016 certification validates the rigor of our processes and reinforces our commitment to quality and risk-based decision-making throughout our organization."

About Amend Surgical

Founded in June 2015, Amend Surgical is focused on the development and commercialization of novel materials for the oral surgical and dental market. In 2020, Amend Surgical licensed the exclusive rights for a novel, tough, surgical adhesive for dental and oral surgical applications from the Wyss Institute at Harvard University. Amend Tissue Tape™ is a wound and barrier technology that forms long lasting ionic and covalent bonds that tightly interconnect the tough adhesive to biologic tissue, even in challenging wet environments like the oral cavity. In 2026 we anticipate launching Amend Tissue Tape™ as well as NanoFUSE™ for use in dental applications. For more information visit www.amendsurgical.com

Media Contact

Robby Lane
CEO
Amend Surgical, Inc.
14000 NW 126th Terrace
Alachua, FL, 32615
844-281-3169
[email protected]

SOURCE Amend Surgical