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Imaging3, Inc. (OTCQB: “IGNG”) Announces execution of agreement with CriTech Research to Complete Software Verification, Validation and Remediation for the Company’s Planned FDA 510(k) Application
Imaging3, Inc. (OTCQB: “IGNG”) Announces execution of agreement with CriTech Research to Complete Software Verification, Validation and Remediation for the Company’s Planned FDA 510(k) Application.
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[{"type":"text","content":"\n\n BURBANK, Calif., Sept. 14, 2016 (GLOBE NEWSWIRE) -- Imaging3™, Inc. (the “Company”) (OTCQB:IGNG) announced today that on August 26, 2016 the Company signed a DVIS Software Remediation Proposal with CriTech Research, Inc. of Saline, MI (“CriTech”), by which CriTech agrees to document, verify and validate the Company’s patented device software for presentation to the United States Food and Drug Administration (the “FDA”) as part of the Company’s planned submission of an application for a 510(k) approval for its Volumetric Imaging Scanner (the “VIS”). The project actually commenced on August 25, 2016.\n CriTech, an acknowledged industry leader, develops and tests safety-critical software and systems for medical device applications. They have more than 20 years of experience creating custom solutions, tailored to meet its clients’ specific FDA software approval needs. Their comprehensive understanding of the software verification, validation and remediation requirements of the medical device industry has resulted in FDA approval and the grant of European Union CE Mark for hundreds of devices. CriTech’s customers range from large, established companies to startups, with products from all FDA device classes (I, II, III) and IEC 62304 software safety classifications (A, B, C). Their proven history of success with medical device software validation & verification and remediation extends to over 380 devices completed – all of them receiving first-time FDA and/or EU approval. Dane Medley, Chairman/CEO of Imaging3 commented, “We are very pleased that CriTech has agreed to act as our software advocate in connection with the FDA 510(k) application and approval process for the 'VIS', even after our arduous reorganization process, of which they were aware every step of the way. CriTech’s no nonsense approach to software verification, validation, and remediation in the medical field fits well with our Company’s overall approach and their proven success rate lends undeniable credibility to our project. To have a truly best in class firm like CriTech as a working partner as we prepare to approach the FDA with our 510(k) application engenders confidence in the Company’s management and investors. This step helps us continue to b...