Set-up of ISO 13485 standards for 3D-printing technologies in hospital environment

Details

Supervisors

Khanh TRAN DUY ; Benoit Herman

Faculty

Ecole polytechnique de Louvain

Degree label

Master [120] : ingénieur civil mécanicien, à finalité spécialisée

Abstract

The ISO 13485 quality management system (QMS) acts as a roadmap for medical device organizations to ensure consistent production of safe and effective products. Since ISO 13485 is harmonized with the QMS part of the Medical Device Regulations (MDR), it is helpful for a medical technology department. In view of this scenario, the work carried out during this internship contributes to the evaluation of the ISO13485 process, focusing on critical elements such as biocompatibility, risk analysis, maintenance, and controls designed to meet the specific needs of the hospital environment. This internship report details the adaptation of a Quality Management System (QMS) from 3D-Side company to develop a template QMS for a Point of Care 3D Printing (POC3DP) pilot within a hospital, applicable with various compliant 3D printing technologies. Point-of-Care (PoC) can be deceptive; while it typically refers to activities carried out "at the patient's bedside," in the context of 3D printing technology, it denotes actions taking place "at the Healthcare Facility." Given the specialized nature of 3D printing in the medical field, an in-depth analysis of the ISO 13485 processes is conducted to accurately assess associated risks and implement the necessary controls to ensure the technology's safe use. Ultimately, the development of a well-structured ISO 13485 QMS fosters a culture of quality within the hospital, leading to improved patient safety and increased trust from requesters and regulatory bodies.