Client Case Study
Design
Development
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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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