Quality & Safety

At Artivion, quality and patient safety are fundamental to everything we do. Our Quality Management System provides the framework for designing, manufacturing, processing, controlling, and distributing products in accordance with applicable regulatory requirements and our established quality standards.

Collectively, our Artivion 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. We accomplish this goal by complying with applicable regulatory and customer requirements and by, maintaining the effectiveness of the Quality Management System, and through the establishment and review of quality objectives.

Our Quality Management System incorporates applicable U.S. FDA requirements, including 21 CFR Part 820 – Medical Devices, Quality Management System Regulation (QMSR), and 21 CFR Part 1271 – Human Cells Tissues and Cellular and Tissue-Based Products. It also incorporates applicable international and regional requirements, including ISO 13485:2016, the European Union Medical Device Regulation (EU) 2017/745, and medical device and tissue requirements where are products are distributed.

Through employee training, quality objectives, performance monitoring, management review, and continual improvement activities, Artivion works to maintain an effective Quality Management System and consistently meet the needs of patients, healthcare professionals, customers, and regulatory authorities.

Certifications and Registrations

Artivion maintains applicable regulatory registrations, licenses, and quality certifications for its operations, facilities, products, and markets. All Artivion medical device manufacturing sites are certified to ISO 13485:2016 within the scopes identified on their respective certificates. Certain sites are also certified under the Medical Device Single Audit Program (MDSAP), as identified on the applicable certificates. Artivion facilities maintain U.S. FDA establishment registrations and other regulatory registrations and licenses, as applicable to their activities and the markets they serve.