Amend Surgical Achieves ISO 13485:2016 Certification
Amend Surgical, a medical device company dedicated to advancing oral wound-care solutions and regenerative biomaterials, is thrilled to announce that it has attained ISO 13485:2016 certification. This prestigious certification is recognized worldwide as the benchmark for medical device quality management systems, signifying the company's unwavering commitment to maintaining high standards in its operations.
Significance of ISO Certification
This certification reaffirms Amend Surgical's focus on safety and regulatory compliance. It demonstrates that the company upholds comprehensive, auditable processes throughout the design, development, and manufacturing of its innovative products, such as the NanoFUSE™ bone graft technologies. With this key milestone, Amend Surgical is on a robust path as it prepares to launch a new generation of oral surgery solutions, including the anticipated Amend Tissue Tape™.
Progress Toward Regulatory Approval
Robby Lane, CEO and co-founder of Amend Surgical, expressed his excitement about this milestone. He stated, "Achieving ISO 13485 certification validates the strength of our quality systems and establishes a crucial foundation for the next stage of our growth. As we move towards the expected regulatory clearance for Amend Tissue Tape™, this certification ensures we meet the highest global standards for safety and performance.”
Ensuring Quality and Compliance
The ISO 13485 certification process included a thorough review of Amend Surgical's quality management system. The evaluation covered key areas such as design controls, supplier management, process validation, and risk management, further solidifying the company’s ability to scale effectively and improve manufacturing capabilities for both its proprietary products and those developed in collaboration with partners.
Commitment to Customer Safety
Carol Muniz, Director of Quality Assurance, emphasized the company's long-standing commitment to customer safety: "Providing our customers with safe, high-quality medical devices has always been our top priority. This certification confirms the rigor of our processes and underscores our dedication to quality and risk-based decision-making throughout our organization."
About Amend Surgical
Established in 2015, Amend Surgical focuses on developing and commercializing innovative materials for the dental and oral surgical markets. Notably, in 2020, the company secured exclusive rights to a pioneering surgical adhesive for dental use from the Wyss Institute at Harvard University. The Amend Tissue Tape™ represents a breakthrough in wound and barrier technology, creating strong ionic and covalent bonds with biological tissue even in challenging wet environments like the oral cavity. Both Amend Tissue Tape™ and NanoFUSE™ are expected to revolutionize dental applications upon their launch in the coming years.
Media Contact Information
For media inquiries or additional information, please contact:
Robby Lane
CEO
Amend Surgical, Inc.
14000 NW 126th Terrace
Alachua, FL, 32615
844-281-3169
Frequently Asked Questions
What is the significance of ISO 13485:2016 certification?
ISO 13485:2016 certification is an international standard ensuring that manufacturers maintain high-quality management systems in the production of medical devices.
What products does Amend Surgical focus on?
Amend Surgical specializes in innovative oral care products, including the upcoming Amend Tissue Tape™ and NanoFUSE™ for dental applications.
Why is the launch of Amend Tissue Tape™ important?
The launch of Amend Tissue Tape™ aims to improve oral surgical outcomes by providing enhanced wound and barrier technologies.
How does Amend Surgical ensure product safety?
Amend Surgical commits to rigorous quality controls and processes that adhere to international safety standards, particularly highlighted by their ISO certification.
What is the future direction of Amend Surgical?
Amend Surgical aims to advance its product pipeline for oral surgery solutions while ensuring compliance and quality in its manufacturing processes.
