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Regulatory Compliance

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

The medical industry mandates the most detailed and rigorous set of regulatory development requirements, design control procedures and certifications of any product market. MIDI has decades of knowledge and experience within this world.

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.

Our procedure and process includes documented design inputs, plans, outputs, hazard & mitigation risk analysis, verification & validation, DHF, formal design reviews, and design transfer.

We strive to generate programs that meet stringent quality and regulatory standards while infusing and maintaining innovative design and engineering from project kick-off to completion.