Establishing a Quality Management System for Production of Certified Customised Titanium Medical Implants through Additi
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MRS Advances © 2020 Materials Research Society DOI: 10.1557/adv.2020.192
Establishing a Quality Management System for Production of Certified Customised Titanium Medical Implants through Additive Manufacturing W B du Preez, D J de Beer and G J Booysen Centre for Rapid Prototyping and Manufacturing, Central University of Technology, Free State, Bloemfontein, South Africa
ABSTRACT
Various cases of medical implants produced through additive manufacturing (AM) in Ti6Al4V have been reported in literature. Not all manufacturing processes used, were qualified. In striving to deliver certified AM medical implants and devices, an ISO 13485:2016 quality management system was implemented in the Centre for Rapid Prototyping and Manufacturing (CRPM) of the Central University of Technology, Free State (CUT) in Bloemfontein, South Africa. This certification is valid for design, development and production of patient-specific custom-made titanium implants, preoperative models, jigs and cutting-guides in nylon through AM, and contract-production of these products. For maintaining this quality management system, the generation of data to validate the individual processes in the AM process-chain is crucial to prove the DMLS product-quality of CRPM’s products. During the past five years, directed research data was produced and published to prove that medical implants produced through DMLS can fully comply with the accepted international standards for material, physical, chemical and mechanical properties of such parts. The paper discusses the quality management system’s establishment; materials research projects executed to generate validation data are mentioned; and examples of customised titanium implants for restoring the quality of life of patients are shown. INTRODUCTION Engineers of the Centre for Rapid Prototyping and Manufacturing (CRPM) of the Central University of Technology, Free State (CUT), in collaboration with leading maxillofacial and orthopaedic surgeons, have designed and produced numerous implants through direct metal laser sintering (DMLS) of Ti6Al4V (ELI) powder, that 1387
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were successfully utilised in facial and skeletal reconstruction [1]. For acceptance of this technology by industry, quality management across the product life cycle and directed research to prove the reliability and repeatability of the DMLS production process chain are required. This drive towards full qualification of medical implants produced through DMLS aligns with the priorities of the South African Additive Manufacturing Strategy [2]. From an innovation and commercialisation perspective, the localisation of customised implants offer a significant financial and job creation reward. The Fitch South Africa Medical Devices Report, Q2 2019, shows a total expenditure of US$153.7 million for 2018 for orthopaedics and p
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