#United States #ISO Certification #Alachua #Amend Surgical #Tissue Tape

Amend Surgical Achieves ISO 13485 Certification

Amend Surgical, a company dedicated to innovating products in oral wound care and regenerative biomaterials, has announced its significant achievement of obtaining ISO 13485:2016 certification. This certification denotes compliance with a globally recognized standard for medical device quality management systems. The actualization of ISO 13485 certification symbolizes the company’s unwavering commitment to ensuring safety, regulatory compliance, and operational excellence across its product lines.

The path to certification involved a rigorous evaluation of Amend Surgical’s quality management infrastructure, verifying robust processes surrounding the design, development, and manufacturing of its advanced NanoFUSE™ bone graft technologies. According to Robby Lane, the company’s CEO and Co-Founder, this accolade marks a crucial step forward for Amend Surgical, validating the resilience of its quality systems and laying down a vital foundation for future growth. “Receiving ISO 13485 certification validates the strength of our quality systems and establishes a critical foundation for the next stage of our growth,” Lane remarked.

As Amend Surgical progresses towards the anticipated regulatory clearance for its innovative product, Amend Tissue Tape™, slated for launch later this year, the certification assures that they are operating within the highest global standards for safety and performance. This milestone enables the company to efficiently scale its operations while enhancing manufacturing capabilities not only for its proprietary offerings but also for partner products in the pipeline.

The comprehensive assessment required for ISO 13485 certification included analyzing various elements of the quality management system, such as design controls, supplier management, process validation, documentation, risk management, and post-market surveillance. As a result, this achievement confirms Amend Surgical’s dedication to delivering superior medical devices to customers, with a focus on comprehensive quality and risk-based decision-making strategies throughout the organization.

Carol Muniz, the Director of Quality Assurance at Amend Surgical, emphasized that providing customers with safe, high-quality medical devices has always been a top priority. “ISO 13485 certification validates the rigor of our processes and reinforces our commitment to quality and risk-based decision-making throughout our organization,” she stated.

Amend Surgical was founded in June 2015 and has concentrated its efforts on developing and commercializing groundbreaking materials tailored for the oral surgery and dental market. A major milestone occurred in 2020 when the company secured exclusive rights to a state-of-the-art, durable surgical adhesive specific to dental and oral surgical applications, sourced from the renowned Wyss Institute at Harvard University.

The anticipated introduction of Amend Tissue Tape™ represents a transformative advancement in surgical technology. This innovative product, combined with NanoFUSE™, aims to redefine wound management in dental applications, harnessing the power of advanced wound and barrier technology that forms lasting ionic and covalent bonds with biologic tissue. This capability is critical, particularly in challenging, wet environments like the oral cavity where traditional adhesives often fail.

Looking ahead, Amend Surgical is fervently preparing for the launches of both Amend Tissue Tape™ and NanoFUSE™ in 2026. These exciting developments signify the company’s ambition to reshape the landscape of oral treatments and supply healthcare professionals with superior tools for improved patient outcomes.

For additional details on Amend Surgical’s innovative products, visit their official website at www.amendsurgical.com.

In conclusion, Amend Surgical’s recent achievement of ISO 13485 certification is a testament to the company’s dedication to enhancing patient care through quality innovation, setting a clear path forward for their upcoming product launches and overall mission in the medical device field.