IntuBlade

IntuBlade aims to eliminate complications and save lives by reducing the number of unnecessary infections, brain damage, and deaths caused by intubation procedures, which currently cost a collective $9 billion annually.

What we delivered:

  • 513(g) submission with FDA

  • Regulatory Strategy

  • Design & Development Plan

  • ISO 13485 compliant Quality Management System (QMS)

  • Feasibility testing

  • Design Inputs

  • Design Outputs & Design Review to support Design History File

  • Mechanical design, hands-on prototyping

  • component sourcing & contract manufacturer management

  • Risk Management, incl. Hazard Analysis

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