Our breath of experience and product knowledge in the medical device industry makes us a unique fit and valuable partner to any OEM or contract supplier in Southern California.

Medical Device

• ​Class I, II and III Products
• Implants
• Disposables
• Instrumentation & Capital Equipment

​

Contract Manufacturing,
Design & Services

• ​​Service Providers which are project focused offering Quality, R&D, Regulatory and Test services
• Specialty Design Studios
• Contract Manufacturers

Biotechnology & Pharma

• ​In Vitro Diagnostics
• Combination Products​
• Manufacturing​

SQUARE-1 PROJECT EXPERTISE

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
  

---

Square-1's Service Capabilities:

Consulting Services

CAD Outsourcing

In-Source Project Services

---