Research & Development

New Product Idea Evaluation

• Design Inputs
• Products Configuration
• Preliminary Quality/Regulatory/Clinical Plan
• Preliminary Sales/Marketing Plans
• Intellectual Property Research
• Risk Management

Preliminary Product Specification

• Design Schedule
• Prototype Documentation
• Risk Management

Research & Development

• Design Verification/Validation
• Clinical Trial or Clinical Evaluation
• Essential Requirement Checklist
• Preliminary Manufacturing Plan
• Risk Management

Prototyping & Bench Function Test

• Prototype/Technical File
• Product Test
• Risk Management

Mold Making and Plastic Parts,
Metal Parts and Electric Parts

• Manufacturing Documentation
• Manufacturing Plan
• Process Validation
• Risk Management

Pilot-Run Preparation and Clinical Test

• Manufacturing Documentation
• Manufacturing Plan
• Process Validation
• Risk Management
• Usability studies
• Pre-clinical study engineering and product support
• Clinical study engineering and product support