Imaging3 Inc. has hired Intertek Inc. to oversee hazard analytics and U.S. Federal Drug Administration guidance protocols during the submission of the company’s Dominion VI imaging device with patented SmartScan 3D technology.
“We continue to have extraordinarily high standards in our selection of vendors,” Imaging3 President Dane Medley said in a statement. “The engagement of Intertek is yet another example, along with Med-Device Consulting, who is assisting with our 510K applications generally, and CriTech Research, who is assisting with the immense software component of our Dominion VI imaging device. This game-plan of working only with the best maximizes our chances of a successful outcome with the FDA.”
Imaging3 noted that Intertek has established itself as an industry leader with more than 130 years in business. Intertek will make sure the Dominion VI product meets quality, health, environmental, safety and social accountability standards.
“It is heartening to witness the transformation of Imaging3,” Intertek's special consultant Scott Pancoast said. “The team has been successful in stabilizing its financials and now it is making great progress in stabilizing its operations. Choosing the right vendors is key, especially when working with complex regulatory matters.”
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