Our breath of experience and product knowledge makes us a unique fit and valuable partner to any product design or manufacturing company in southern California.

Product Development

• Design Services (Solidworks, Pro-E & Catia)
• Drafting
• Design Library Maintenance
• Product ​Verification & Validation
• Material Research & Selection
• Product Environmental Testing
• d/pFMEA & FEA

Manufacturing

• Process Improvements
• Kaizen Events
• Tool & Fixture Design
• Auditing: Internal & Suppliers
• Equipment Verification & Validation
• Product Commercialization
• ​CAPA & NCR Initiation & Closure
• Facility Layout & Transfer

Quality

• Product, Process & Equipment ​Verification & Validation​
• ​483 Remediation Support
• Quality System Development
• Tech Transfer
• Risk Management
• ​CAPA & NCR Initiation & Closure

Regulatory

• EU MDR & IVDR Transition
• Regulatory Compliance
• 510k, PMA & CE Mark Submission Support & Oversight
• ​483 Remediation Support
• Quality System Development
• DO160 Documentation Development​

Embedded Systems

• Safety Critical Device Software
• Emb RTOS, Linux and Win Apps
• iOS, Android, and Wearables
• Cloud Data Collection and Remote Diagnostics
• Advanced Test Systems
• FDA and IEC 62304 Reg Compliant 

Technical Support

• Document Control
• Technical Writing
• ​Intellectual Property Transfer
• Technician Support (R&D, Manufacturing, Inspection)
• ​Tribal Knowledge Transfer
  

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Square-1 Engineering, Inc