QUALITY MANAGEMENT AND REGULATORY INTEGRATION IN THE DEVELOPMENT OF BIOMATERIAL-BASED CARDIOVASCULAR DEVICES

The research and development activities carried out at Assut Europe S.p.A. focused on the optimization of biomaterials for advanced vascular devices intended for cardiac surgery applications, with particular emphasis on biological matrices derived from bovine pericardium. Building on previous activities involving biomaterial characterization, the development and optimization of crosslinking protocols, and preliminary assessments of mechanical properties and enzymatic stability, the work further investigated the integration of regulatory requirements and quality management principles into the various stages of the medical device development process. The activities included an analysis of Regulation (EU) 2017/745 on medical devices (Medical Device Regulation, MDR) and the ISO 13485 standard, with the aim of defining the framework for integrating research and development activities within a quality management system applicable to implantable medical devices [1,2]. Particular attention was devoted to the traceability of experimental activities, the reproducibility of results, and systematic process control, which are essential elements for ensuring the reliability of generated data and the appropriate documentation of development stages. In collaboration with the Quality Assurance (QA) department, aspects relating to technical documentation, the definition and validation of operating procedures, and applicable manufacturing process requirements were examined. The activities included the standardization of procedures for the decellularization, crosslinking, and sterilization of biological matrices, together with the systematic collection and organization of critical process parameters. These parameters included reagent concentrations, exposure times and conditions, storage conditions, and sample handling procedures, with the aim of promoting experimental reproducibility and controlling variables that may affect the final characteristics of the biomaterial. A further area of investigation concerned risk management associated with the use of animal-derived biomaterials, with particular reference to biological and mechanical hazards and their implications for device safety and performance. The adopted approach integrated experimental evidence with quality assurance principles and applicable regulatory requirements, contributing to the consolidation of a structured and documented development pathway. Overall, these activities supported improvements in the methodological robustness of the development process and the assessment of the transferability of experimental findings to industrial manufacturing, with a view to developing biomaterial-based cardiovascular devices.