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Tim Torbenson
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Here is an excerpt from an article in the August issue of IDT titled "Under the Microscope". The article provides critical information on the FDA and the CAD/CAM dental lab.
“Dental laboratories, whether they wanted to or not, have evolved from a cottage industry to manufacturers of product,” says Tim Torbenson, founder and president of EVO820, a company that offers quality management and compliance services to small to medium laboratories, located in Rancho Mission Viejo, CA. “And it’s to the manufacturers of product that the FDA pays attention.” The potential for large quantities of CAD-designed or CAM-milled restorations produced by machines that perhaps were not properly calibrated, operated, or maintained is what has caught the eye of regulatory agencies. Although most laboratories have put some form of QMS and GMPs in place for day-to-day operations—like remakes, equipment maintenance, employee job descriptions, and training—it’s documenting each of these routines that is often missing.
Here is a link to the entire article: http://www.dentalaegis.com/idt/2017/08/under-the-microscope
“Dental laboratories, whether they wanted to or not, have evolved from a cottage industry to manufacturers of product,” says Tim Torbenson, founder and president of EVO820, a company that offers quality management and compliance services to small to medium laboratories, located in Rancho Mission Viejo, CA. “And it’s to the manufacturers of product that the FDA pays attention.” The potential for large quantities of CAD-designed or CAM-milled restorations produced by machines that perhaps were not properly calibrated, operated, or maintained is what has caught the eye of regulatory agencies. Although most laboratories have put some form of QMS and GMPs in place for day-to-day operations—like remakes, equipment maintenance, employee job descriptions, and training—it’s documenting each of these routines that is often missing.
Here is a link to the entire article: http://www.dentalaegis.com/idt/2017/08/under-the-microscope
