Quality and Safety

 

CryoLife’s Commitment to Excellence in Patient Safety

CryoLife’s comprehensive Quality System is designed to achieve high quality standards through strict levels of quality control. CryoLife’s achievement of quality is indicative of the importance placed on meeting patients’ and customers’ needs and is exemplified by the high quality products being offered.

Collectively, our CryoLife team owns Quality. Our goal is that each team member uniquely applies personal accountability in all areas of our business to those we are entrusted to serve.

CryoLife’s Quality Management System is in accordance with 21 CFR Part 820 – Medical Devices, Quality System Regulation, 21 CFR Part 1270 – Human Tissue Intended for Transplantation, and 21 CFR Part 1271 – Human Cells Tissues and Cellular and Tissue Based Products. CryoLife’s Quality Management System also incorporates the requirements of applicable ISO Standards, as well as European Medical Device Directives and Human Tissue Product Regulations, Australian Medical Device and Tissue Requirements, Health Canada Medical Device Regulations, and Health Canada Tissue Regulations.

CryoLife emphasizes a total quality assurance approach to all aspects of business. Awareness of Quality Systems and procedures is maintained through employee training and is practiced company-wide.

The CryoLife Quality Management System provides the organizational structure to ensure that products are processed, manufactured, controlled, and distributed according to the appropriate regulatory requirements and corporate policies/procedures. Continuous quality improvement is the basis for the Quality Management System. The periodic reviews of the system identify the strategic plans required to develop, implement, and modify the Quality Management System and identify the processes, controls, equipment, fixtures, resources, and skills necessary to meet ongoing quality requirements.

CryoLife, Inc. is a U.S. FDA-registered medical device establishment (Registration # 1063481) and human cells, tissues, and cellular and tissue-based product establishment (#3001451326). In addition, CryoLife is licensed or registered by the States of Georgia, New York, Florida, California, Maryland, Pennsylvania, Illinois, and Delaware. CryoLife is certified to the international quality standards (ISO 13485:2003) for the design, manufacture, and distribution of tissues and medical devices. CryoLife’s Microbiology Laboratory is a State of Georgia licensed Clinical Laboratory, is a federally licensed CLIA Laboratory, and participates annually in the College of American Pathologists (CAP) Performance Surveys.

Certificates and Licenses

American Association of Tissue Banks (AATB) Certificate

US FDA Annual Registration of Device Establishment

US FDA Establishment Registration for Human Cells, Tissues, and Cellular and Tissue-Based Products HCT/P (2017)

Clinical Laboratory Improvement Amendments (CLIA) Certificate

State of California Tissue Bank License

State of Florida Tissue Bank License

State of Georgia Clinical Laboratory License

State of Illinois Letter of Registration

State of Maryland Tissue Bank Permit

State of Maryland Medical Laboratory Permit

State of New York Tissue Bank License

State of Oregon Letter of Registration 2014-2017

State of Pennsylvania Drug & Device Registration

ISO 13485:2003 Certificate of Approval UKAS

ISO 13485:2003 Certificate of Approval SCC/CMDCAS

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