UF Innovate | Accelerate client Amend Surgical, a medical device company focused on novel products for oral wound-care and regenerative biomaterials, 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.
Read more about Amend Surgical Proudly Announces ISO 13485 Certification, Advancing Toward Launch of Amend Tissue Tape™
