R&D activities at Assut Europe focused on optimizing bovine pericardium-derived biomaterials for cardiovascular devices used in cardiac surgery. Building on previous work on material characterization, crosslinking protocols and mechanical and enzymatic stability, the study integrated regulatory and quality requirements (MDR 2017/745 and ISO 13485) into the development process [1,2], with emphasis on traceability, reproducibility and process control. In collaboration with Quality Assurance, the operating procedures for decellularization, crosslinking and sterilization were standardized, critical process parameters were systematically collected, and the risks associated with animal-derived materials were assessed. This approach strengthened the development pathway, supporting the safety, efficacy and industrial transferability of the devices.
QUALITY MANAGEMENT AND REGULATORY INTEGRATION IN THE DEVELOPMENT OF BIOMATERIAL-BASED CARDIOVASCULAR DEVICES
Carola Agostinone
;Barbara Barboni;Valentina Russo;
2026-01-01
Abstract
R&D activities at Assut Europe focused on optimizing bovine pericardium-derived biomaterials for cardiovascular devices used in cardiac surgery. Building on previous work on material characterization, crosslinking protocols and mechanical and enzymatic stability, the study integrated regulatory and quality requirements (MDR 2017/745 and ISO 13485) into the development process [1,2], with emphasis on traceability, reproducibility and process control. In collaboration with Quality Assurance, the operating procedures for decellularization, crosslinking and sterilization were standardized, critical process parameters were systematically collected, and the risks associated with animal-derived materials were assessed. This approach strengthened the development pathway, supporting the safety, efficacy and industrial transferability of the devices.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
