Sigma Labs Inc (SASI)

[GetRich1day]

Latest FDA guidance November 2016 on Quality Metrics. Getting closer to SGLB's time??

For emerging technology, the use of new, in-line analytical technology used for real time release testing with increased sensitivity might result in better detection of in-process OOS results used for Real Time Release Testing and thus, a temporary increase in total OOS results. However, improved detection that allows for the diversion and rejection of poor quality product will provide improved assurance of quality. In this instance, it may be appropriate to provide an explanation that new, improved technology was implemented and that there is data demonstrating that more robust product was released to the market as a result of this change

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm455957.pdf

FDA's draft guidance recommends using test coupons, defined by the agency as "a representative test sample of the device or component," for process validation. Cola said that in that same vein, the PrintRite3D system provides "witness coupons." These "become a record of the build and provide a link back to the quality and repeatability of the process," he explained.

"Our unique selling point comes from the fact that we've gone to the trouble of taking the information we gather and [made] it actionable for the end-user, the manufacturing engineer on the floor," said Cola.

The agency's draft document is also helping to close that gap, Cola said. "Things like the FDA guidelines bascially pave that bridge that we've established with our software."

http://www.mddionline.com/blog/devicetalk/how-apply-fdas-3-d-printing-guidance-medtech-manufacturing-09-23-16

Tick-Tock-Tick-Tock goes the clock.