Table 6.

Quality management systems, control gates, and technologies used by the three studied companies.

Company	Quality System and Certifications	Number of Quality Control Gates	Technologies Used for Quality Control
A	ISO 9001:2015 ISO 13485:2016 ISO 14001:2015 ISO/IEC 27001:2013 Council Directive 93/42/EEC	15	Biomedical software package Finite element analysis software Powder handling and sieving AM equipment Real time AM process monitoring system Micro CNC 5 + 1 axis milling machine Tactile and laser 3D coordinate measuring system Micro-CT scanner Light optical microscope X-Ray fluorescence spectrometer Surface roughness tester
B	ISO 13485:2016 Council Directive 93/42/EEC	14	Biomedical software package Finite element analysis software Powder handling and sieving AM equipment Real time AM process monitoring system Tactile 3D coordinate measuring system Industrial X-ray machine Light optical microscope X-Ray fluorescence spectrometer Surface roughness tester Fatigue testing machine Universal testing machine
C	ISO 9001 ISO 13485 AS9100 MPIF Standard 35	12	Finite element analysis software Powder handling and sieving AM equipment Real time AM process monitoring system Tactile 3D coordinate measuring system Optical measuring system Light optical microscope X-Ray fluorescence spectrometer Surface roughness tester Fatigue testing machine Universal testing machine