Quality Assurance
HC Biologics’ management and employees are committed to maintaining a quality assurance program that effectively complies with applicable federal and state regulations; implements industry best-practices and ensures customer requirements are met.
- HC Biologics is registered as a Tissue Establishment with the U.S. Food and Drug Administration (FDA).
- HC Biologics is registered as a Medical Device Manufacturer with the U.S. FDA.
- HC Biologics’ quality system is certified to both ISO 9001 and ISO 13485 Medical Devices Quality Management Systems.
- HC Biologics only accepts donor tissues sourced from FDA registered and AATB (American Association of Tissue Banks) accredited facilities in the United States.