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  SERVICES:
MEDTECH CONSULTING
Expertise in Class II & III ​R&D, RAQA & Mfg Engineering
CAD
​SERVICES
Mechanical & Electrical Design, Drafting & cGMP Documentation
 TECHNICAL TRAINING
From Regulations & Compliance to CAD, We've Got Your Team Covered
​Click on the button or icons above to learn how Square-1's services help our
​customers solve their business challenges.

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