Sigma Labs Inc (SASI)

[GetRich1day]

3D Standards are slowly coming to fruition. These standards and guidance is needed especially to address critical metallic AM applications. This is where PrintRite3D will fit after the standards and guidance is set and mass production of critical metallic parts fully begins.

As with most types of medical devices, FDA says it expects devices manufacturing using additive manufacturing techniques to adhere to quality systems requirements in order to ensure devices perform as intended.

But because there are multiple additive manufacturing technologies, printers and materials, FDA says it is important for manufacturers to "clearly identify each step in the printing process… from the initial device design to the post-processing of the final device."

- See more at: http://www.raps.org/Regulatory-Focus/News/2016/05/09/24901/FDA-Issues-Long-Awaited-3D-Printing-Guidance-for-Medical-Devices/#sthash.F9Vs2diU.dpuf

For validated processes, the monitoring and control methods and data must be
documented.11 718 Methods for ensuring the consistency of quality could include:
719
· in-process monitoring12 720 of parameters such as:
721 o temperature at the beam focus,
722 o melt pool size,
723 o build-space environmental conditions (e.g., temperature, pressure,
724 humidity),
725 o power of the energy delivery system (e.g., laser, electron beam,
726 extruder), or
727 o status of mechanical elements of the printing system (e.g., recoater,
728 gantry)

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm499809.pdf