Device Commercializtion Services


Team

- Dedicated project manager
- Dedicated manufacturing engineering
- QA/Regulatory
- Supply chain professionals

Services Provided

- Design for manufacturability - Design for process capability, Design for assembly,Design to cost, Design verification ~Proving Design Outputs meet Design Inputs
- Process Validation
- Transfer to production - repeatable and reliable production process
- Design History File and Device Master Record

Infrastructure

- Dedicated pilot manufacturing lines
- Class 100,000 clean rooms
- Vertically integrated component sourcing
- FDA Registered Contract Manufacturer

Proven product development process

- Projects executed to ISO and FDA standards
- Design History Files and Device Master Records
- Supply chain development
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