Surgeons

Safe, effective, and quality products to all healthcare professionals

Quality

At HC Biologics, we are committed to maintaining the highest quality standards across every aspect of our operations. Our products undergo rigorous testing and quality control procedures to ensure their safety, efficacy, and reliability. We also follow strict regulatory guidelines and maintain robust quality management systems that enable us to consistently deliver high-quality biologic solutions.

HC Biologics’ management and employees are committed to maintaining a quality assurance program designed to comply with applicable federal and state regulations, incorporate industry best practices, and ensure that our customers’ requirements are met.

As part of this commitment:

HC Biologics is registered with the U.S. Food and Drug Administration (FDA) as a Tissue Establishment.
HC Biologics is registered with the FDA as a Medical Device Manufacturer.
HC Biologics’ Quality Management System is certified to ISO 9001 and ISO 13485 standards.
HC Biologics exclusively accepts donor tissue sourced from establishments located in the United States that are registered with the FDA and accredited by the American Association of Tissue Banks (AATB).

Processing

The processing and manufacturing steps followed at HC Biologics are designed to maximize the gift of donation as well as producing the most advanced medical solutions in multiple disciplines, while assuring the safety of the end-user by providing safe and sterile tissue and medical devices. Each stage of the process has been designed and validated to ensure patient safety.  

We employ state-of-the-art processing techniques to maximize the therapeutic potential of our biologic products. Our advanced processing methods preserve the integrity of the biomaterials, ensuring optimal biological activity and clinical performance. Our team of experts follows stringent protocols and utilizes cutting-edge technologies to ensure the highest quality standards are met throughout the processing stages.

Safety

Patient safety is our top priority. Our biologic solutions undergo rigorous screening, testing, and validation to ensure they meet stringent safety standards. We follow industry best practices to minimize potential risks associated with our products and prioritize patient safety at every stage of manufacturing and distribution.

As an ISO 13485-certified manufacturer, HC Biologics operates under a rigorous Quality Management System. We strictly follow this standard to ensure that our manufacturing processes and quality systems consistently meet regulatory and customer requirements. ISO 13485 compliance demonstrates our commitment to providing safe and effective solutions to our network of surgeons and distributors, all focused on achieving the highest level of patient satisfaction.

All tissue and blood samples undergo infectious-disease testing by a CLIA-certified laboratory, including HIV and HCV screening using Nucleic Acid Testing (NAT by TMA)—one of the most reliable methods currently available for early detection following exposure. HC Biologics works exclusively with accredited members of the American Association of Tissue Banks (AATB), ensuring that all testing and processing of donated tissue meet or exceed AATB standards and FDA regulations. All results are reviewed by a team of specialists and physicians in infectious disease, pathology, and tissue banking. Every required communicable disease test listed below must be non-reactive or negative. Our comprehensive testing panel also includes the following:

* Tissues from a donor whose blood specimen is unsuitable for the non-treponemal screening assay, such as the RPR test, or with a reactive result from the non-treponemal screening assay, are cleared for transplantation use only when the result from the treponemal-specific (confirmatory) assay is nonreactive. Non-required screening tests for exposure to other viruses or parasites such as those listed below for may have been performed on the donor by other agencies involved in the donation process. A negative/nonreactive result is not required for these tests; however, all donors are evaluated on a case-by-case basis by the Medical Directors of Tissue Banks we are working with