Safe, effective, and quality products to all healthcare professionals
At HC Biologics, we are committed to maintaining the highest standards of quality in every aspect of our operations. Our products undergo rigorous testing and quality control procedures to ensure safety, efficacy, and reliability. We adhere to strict regulatory guidelines and have robust quality management systems in place to consistently deliver biologic solutions of the utmost quality.
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. Food and Drug Administration (FDA).
HC Biologics’ quality system is certified with 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.
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.
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 any potential risks associated with our products. We prioritize patient safety at every step of the manufacturing and distribution process.
As an ISO 13485 certified manufacturer that has been implementing the paramount level of Quality Management Systems: At HC Biologics, we strictly adhere to this standard to ensure that our manufacturing processes and quality management systems consistently meet regulatory and customer requirements. Compliance with ISO 13485 demonstrates our commitment to delivering safe and effective solutions to our network of surgeons and distributors which aim nothing but the highest level of patient satisfaction.
All tissue and blood samples are tested for infectious diseases by a CLIA Certified Lab, including testing for AIDS with Nucleic Acid Testing (NAT by TMA) — the newest and most reliable test to confirm the presence or absence of HIV and HCV early following exposure. As HC Biologics only works with accredited members of the American Association of Tissue Banks (AATB), all testing and processing of donated tissue meet or exceed all AATB standards and FDA regulations. All test results are evaluated by a team of specialists and physicians from the infectious disease, pathology and tissue banking fields. All required communicable disease tests listed below must be found non-reactive or negative while our comprehensive battery of testing also includes the followings:
* 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