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Regulatory & Certifications

MIDI is an FDA and ISO compliant total product development consulting firm.

MIDI's DevelopmentDNA process is not only our innovation engine, but also our formal design control process for the generation of Design Control Documentation, procedure and Design History Files (DHF) for compliance to the FDA Quality System Regulation; section 21 of the Code of Federal Regulations Part 820.30 and International Standards Organization 13485.

MIDI can also generate full production simulation prototypes (Alpha & Beta) for verification, PRD refinement, concept verification/usability testing as well as test method development through the DevelopmentDNA process. This ensures reliability with robust research design, engineering and human factors supported by a thorough Design History File (DHF).

MIDI infuses and establishes certification requirements necessary for product development at the project kick-off. Through our methodical process of DevelopmentDNA we generate detailed System Analysis reports for design and engineering implementation/testing as related to certifications including UL, IEC, CE, TUV, CSA, ANSI and FDA 510(k).