RE:News: 2016 Development Summary and ReportsIt goes forward. 2016 was a difficult year with delay but it seems Chromedx made great progess. 2017 is harvest time. But finally we need the approval from FDA...
Once the development phase of the biosensor and cartridge are completed the ChroMedX will commence manufacturing and the assembly of prototype devices which will enable the Company to accelerate the testing phase. In parallel, the Company will be developing the documentation for getting accreditation for an ISO13485 Quality System and meeting the FDA Quality Management System requirements. After completion of in-house testing, clinical and regulatory requirement testing phase will commence leading to compiling a complete dossier for FDA 510(k) submission.
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