AmnioFix® QA/Regulatory
Quality Assurance / Regulatory
Our team is dedicated to providing safe, superior bioimplants that exceed customer expectations. To better satisfy the requirements and expectations of our customers, the company maintains strict control on quality from the time of procurement. The Company has developed and implemented a Quality Management System in compliance with both the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB). Using this Quality Management System, the company maintains strict control over each step of the manufacturing process.
In addition to regulating recovery and processing activities, the Company has also established guidelines for donor eligibility, screening and testing. All donor records and test results are reviewed by our Medical Director prior to the release of the tissue. Only tissue from donors that test negative or non-reactive for infectious diseases and acceptable bacterial results are released for transplant.
Licenses and Accreditations
- American Association of Tissue Banks Accreditation
- State of California Tissue Bank License
- Food and Drug Administration (FDA) Establishment Registration and Listing for Human Cells, Tissues and Cellular and Tissue-Based Products
- Maryland Department of Health and Mental Hygiene Tissue Bank Permit
- State of New York Provisional License for Tissue Bank Operation
