Quality, Regulatory & Certifications is a way of life
MIDI is an FDA and ISO compliant total product development firm.
From program kickoff MIDI initiates the DevelopmentDNA™ process, working in concert with the client to identify, detail, and document a Quality, Regulatory, and Certification strategy to be deployed throughout the programs development cycle.
MIDI's DevelopmentDNA™ process is not only our innovation engine but also our formal design control process for the generation of Designed Control Documentation, procedure and Design History Files (DHF) for compliance to the Quality System Regulation; section 21 of the Code of Federal Regulations Part 820.30 and International Standards Organization 13485.
Our procedure and process includes documented design inputs, plans, outputs, hazard & mitigation risk analysis, verification & validation, DHF, formal design reviews, and design transfer.
MIDI is fueled by DevelopmentDNA™ to ensure quality, efficiency, clinical efficacy as well as the mitigation of risk.
We strive to generate programs the meet stringent quality and regulatory standards while infusing and maintaining innovative design and engineering from project kick-off to completion.