EUROPEAN CONGRESS AND EXHIBITION ON ADVANCED MATERIALS AND PROCESSES - EUROMAT 2021

The work presented was carried out in the course of a research project aiming at establishing a 3D printing center at the clinic for the in-house production of patient specific medical products, such as implants, anatomic models, and any kind of tools. Establishing a 3D printing center in a clinic poses many challenges. One of these challenges is the seamless integration in the existing clinical environment in consideration of existing regulatory requirements. As a first step towards this goal a process landscape was created to design the operational level of the 3D printing center. This process landscape serves as an overview and provides insights in the activities for various stakeholders, such as clinical management, quality management, auditors (internal and external), and also for managers and employees of the 3D printing center itself. The process landscape specifies all required processes to run the 3D printing center including mandatory processes required by regulations such as EN ISO 13485 Medical devices - Quality management systems, EN ISO 14971 Medical devices - application of risk management to medical devices, Medical Device Regulations (MDR), or the Medical Devices Act. The processes are clustered in management processes (value-defining), core processes (value-adding), support processes (value-preserving), and research & development processes. Besides that, also strategic elements such as vision and mission, quality policies/quality targets and elements such as customers and products are incorporated in the process landscape for a holistic view on the business. The process landscape is implemented via ADONIS NP to ensure availability for all stakeholders and compliance with constraints of the organization of the clinic. At the current design stage regulatory aspects and constraints are also visualized in the process landscape and will also be presented.