Client Case Study
Design
Development
Manufacturing
Hubly is developing an integrated electric drill system designed to streamline bedside intracranial access, decrease operating room reliance, and facilitate treatment for emerging indications.
What we delivered:
- 510(k) submission, FDA response interaction, and 510(k) clearance (May 2023)
- 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
- FDA Small Business Registration
- 3rd Party Supplier Engagement
- Industrial Design
- 3D Renderings
- CAD models
- PCB Design gerber files
- Packaging and Labeling Design
- Product Photography
- Usability Study Design & Execution
- Contract Manufacturing Services
- Order Fulfillment Services
- 3rd Party Sterilization Management
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