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.”