Square-1 Engineering: A New Approach to Medical Device Consulting

MEDICAL DEVICE EXPERTISE

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

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  • ​Class I, II and III Products
  • Implants
  • Disposables
  • Instrumentation & Capital Equipment
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Contract Manufacturing,
Design & Services

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

Biotechnology & Pharma

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

SQUARE-1 PROJECT EXPERTISE

Product Development
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  • Design Services (Solidworks, Pro-E & Catia)
  • Drafting
  • Design Library Maintenance
  • Product ​Verification & Validation
  • Material Research & Selection
  • Product Environmental Testing
  • d/pFMEA & FEA
Manufacturing
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  • Process Improvements
  • Kaizen Events
  • Tool & Fixture Design
  • Auditing: Internal & Suppliers
  • Equipment Verification & Validation
  • Product Commercialization
  • ​CAPA & NCR Initiation & Closure
  • Facility Layout & Transfer
Quality
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  • Product, Process & Equipment ​Verification & Validation​
  • ​483 Remediation Support
  • Quality System Development
  • Tech Transfer
  • Risk Management
  • ​CAPA & NCR Initiation & Closure
Regulatory
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  • EU MDR & IVDR Transition
  • Regulatory Compliance
  • 510k, PMA & CE Mark Submission Support & Oversight
  • ​483 Remediation Support
  • Quality System Development
  • DO160 Documentation Development​
Embedded Systems
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  • 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
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  • Document Control
  • Technical Writing
  • ​Intellectual Property Transfer
  • Technician Support (R&D, Manufacturing, Inspection)
  • ​Tribal Knowledge Transfer

Square-1's Service Capabilities:
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Consulting Services
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CAD Outsourcing
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In-Source Project Services

    Contact Square-1 Today for Help With Your Technical Project & Resource Needs

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  • Home
  • Square-1 Engineering Services
    • Medical Device Consulting >
      • Product Development Services
      • Medical Device Quality Engineering & Compliance Services
      • Validation Services
      • Manufacturing Services
      • Regulatory Services
    • Medical Device CAD Services
    • In-Source Project Services
  • Successful Execution
    • How We Engage
    • Problems We Solve
    • Project Expertise
    • Case Studies
  • Resource Library
    • White Papers and Articles
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • About Us
    • Vision & Misson
    • Careers >
      • Careers - Business Development Manager
      • Careers - R&D Engineer
      • Careers - Test Engineer
    • Contact Us
  • Home
  • Square-1 Engineering Services
    • Medical Device Consulting >
      • Product Development Services
      • Medical Device Quality Engineering & Compliance Services
      • Validation Services
      • Manufacturing Services
      • Regulatory Services
    • Medical Device CAD Services
    • In-Source Project Services
  • Successful Execution
    • How We Engage
    • Problems We Solve
    • Project Expertise
    • Case Studies
  • Resource Library
    • White Papers and Articles
    • Recommended Business Reading
    • The Business Wingmen Podcast
  • About Us
    • Vision & Misson
    • Careers >
      • Careers - Business Development Manager
      • Careers - R&D Engineer
      • Careers - Test Engineer
    • Contact Us