What we delivered:

• 510(k) submission
• Design and Development Plan
• Market / Product Requirements Specifications (Design Inputs)
• Risk Management Plan
• Preliminary Usability Evaluation
• Preliminary Hazard Analysis
• Quality Plan
• Software Development Plan
• Quality Management System Procedures
• Electromechanical Product Design
• Intellectual Property development
• Design Verification Strategy & Execution
• Packaging and Labeling Design
• Product Photography
• Usability Study Design & Execution

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