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International Journal of Bioprinting                              AM evaluation of medical device companies




            Conflict of interest                                  https://www.iso.org/standard/59752.html  (accessed  on
                                                                  March 6, 2023).
            The authors declare no conflicts of interest.
                                                               6.   Chiarini A. Effect of ISO 9001 non-conformity process on
            Author contributions                                  cost of poor quality in capital-intensive sectors. Int J Qual
                                                                  Reliab Manag. 2015;32(2):144-155.
            Conceptualization:  Alba González Álvarez, Rubén Pérez      doi: 10.1108/IJQRM-03-2013-0041
               Mañanes, José Antonio Calvo Haro, Lydia Mediavilla   7.   Wong K-C, Scheinemann P. Additive manufactured metallic
               Santos, Javier Pascau                              implants for orthopaedic applications.  Sci China Mater.
            Formal analysis: Alba González Álvarez                2018;61(4):440-454.
            Methodology: Alba González Álvarez                    doi: 10.1007/s40843-017-9243-9
            Writing – original draft: Alba González Álvarez    8.   Hothi H, Henckel J, Bergiers S, Laura AD, Schlueter-Brust
            Writing – review & editing: Alba González Álvarez, Rubén   K, Hart A. The analysis of defects in custom 3D-printed
               Pérez Mañanes, José Antonio Calvo Haro, Lydia      acetabular cups: A comparative study of commercially
               Mediavilla Santos, Javier Pascau                   available implants from six manufacturers.  J Orthop Res.
                                                                  2022;(October):1-12.
            Ethics approval and consent to participate            doi: 10.1002/jor.25483
            Not applicable.                                    9.   Martinez-Marquez D, Delmar Y, Sun S, Stewart RA.
                                                                  Exploring macroporosity of additively manufactured titanium
            Consent for publication                               metamaterials for bone regeneration with quality by design: A
                                                                  systematic literature review. Materials (Basel). 2020;13(21):1-44.
            Not applicable.                                       doi: 10.3390/ma13214794

            Availability of data                               10.  Liu X, Chu PK, Ding C. Surface modification of titanium,
                                                                  titanium alloys, and related materials for biomedical
            The processed data about this study can be shared upon   applications. Mater Sci Eng R Rep. 2004;47(3): 49-121.
            reasonable request.                                   doi: 10.1016/j.mser.2004.11.001
                                                               11.  Gonzalez Alvarez A, Dearn KD, Lawless BM, et al. Design
            References                                            and mechanical evaluation of a novel dynamic growing rod
                                                                  to improve the surgical treatment of early onset scoliosis.
            1.   Villapún VM, Carter LN, Avery S, González-Álvarez A,   Mater Des. 2018;155:334-345.
               Andrews JW, Cox S. Stakeholder perspectives on the current      doi: 10.1016/j.matdes.2018.06.008
               and future of additive manufacturing in healthcare.  Int J
               Bioprint. 2022;8(3):586.                        12.  Tammas-Williams S, Withers PJ, Todd I, Prangnell PB. The
               doi: 10.18063/ijb.v8i3.586                         effectiveness of hot isostatic pressing for closing porosity
                                                                  in titanium parts manufactured by selective electron beam
            2.   Food and Drug Administration.  Technical  Considerations   melting.  Metall Mater Trans A Phys Metall Mater Sci.
               for Additive Manufactured Medical Devices: Guidance for   2016;47(5):1939-1946.
               Industry and Food and Drug Administration Staff Document.      doi: 10.1007/s11661-016-3429-3
               Center for Devices and Radiological Health. New
               Hampshire: USA. 2017;1-30.                      13.  Barrère F, Mahmood TA, de Groot K, van Blitterswijk CA.
               https://www.fda.gov/regulatory-information/search-fda-  Advanced biomaterials for skeletal tissue regeneration:
               guidance-documents/technical-considerations-additive-  Instructive and smart functions.  Mater Sci Eng R Rep.
               manufactured-medical-devices (accessed on 16 January   2008;59(1):38-71.
               2024).                                             doi: 10.1016/j.mser.2007.12.001
            3.   Gong H, Rafi K, Gu H, Janaki Ram GD, Starr T, Stucker B.   14.  Suska F, Kjeller G, Tarnow P, et al. Electron beam melting
               Influence of defects on mechanical properties of Ti–6Al–  manufacturing technology  for individually  manufactured
               4V components produced by selective laser melting and   jaw  prosthesis: A case report.  J Oral Maxillofac Surg.
               electron beam melting. Mater Des. 2015;86:545-554.   2016;74(8):1706.e1-1706.e15.
               doi: 10.1016/j.matdes.2015.07.147                  doi: 10.1016/j.joms.2016.03.046
            4.   Regulation (EU) 2017/745 of the European Parliament and   15.  Martinez-Marquez D, Mirnajafizadeh A, Carty CP, Stewart
               of the Council of 5 April 2017 on Medical Devices.   RA. Application of quality by design for 3D printed bone
               https://eur-lex.europa.eu/legal-content/EN/TXT/    prostheses and scaffolds. PLoS ONE. 2018;13(4):1-47.
               PDF/?uri=CELEX:32017R0745 (accessed on 6 March 2023).      doi: 10.1371/journal.pone.0195291
            5.   ISO 13485:2016, Quality Management Systems. International   16.  Van Hooreweder B, Moens D, Boonen R, Kruth JP, Sas P.
               Organization for Standardization, Geneva, Switzerland.   Analysis of fracture  toughness and crack propagation of


            Volume 10 Issue 2 (2024)                       378                                doi: 10.36922/ijb.0140
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