For a medical device to receive regulatory approval, it needs to meet strict standards. Understanding those standards and ensuring the necessary deliverables are executed in the various phases of the device development life cycle is where CX3 can help.

Our Services

Planning Phase


  • Intellectual Property Assistance
  • Technology Analysis
  • Project Management
  • Business Strategy
  • Resource Identification

Product Development Phase


  • Regulatory Guidance
  • Product Requirements Development
  • Risk Management
  • Device Development Guidance
  • Design Control Documentation

Testing & Manufacturing Phase


  • Design Specifications Development
  • Design Verification Testing 
  • Manufacturing & Inspection Procedures
  • Pre-Clinical Testing
  • Human Factors & Usability Analysis