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• Design for manufacturability analysis
• Plastic part design
• Material selection
• Rapid prototyping
• Prototype injection molds for low cost
design verification
• Sterile Package design
• Shipping box design and configuration
• Controlled design and development
from feasibility through pilot production
• Research space and equipment available
for shared development and testing
• Prototype design, assembly,
testing and verification
• Pilot lot testing and validation
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• Assembly process definition and design
• Test procedure definition and design
• Tooling and fixture design and fabrication
• Equipment validations including
I/Q, O/Q and P/Q
• Validation protocol development,
testing and reports
• Sterile package seal strength
characterization
• Sterilization validation
• Accelerated age studies
• Shipping tests
• Full Engineering and
manufacturing documentation
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• Material characterization and sourcing
• Vendor identification and auditing
• Effective planning through MRP processes
and procedures
• High level inbound receiving and inspection
control processes
• Highly accurate inventory control procedures
• Multiple types of warehouse capabilities
and capacity
• Outbound quality specification testing
• Varied methods of distributing product
globally
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• Low to high volume manufacturing
• Injection molding of plastic components
• Sub assembly staging
• Clean room production as needed
• Automation as needed
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