DESIGN CONTROL AND DOCUMENTATION

  • Design control process execution, management and adherence throughout the project life cycle
  • SolidWorks® Product Data Management(PDM) integration for design management
  • ISO 13485:2016 compliance and Implementation
  • Iterative and looped design review process to ensure confirmation against design input requirements throughout product development process
  • A tailored product development process, structured and executed to meet the medical device regulations design control requirements
  • Risk management application and adherence
  • Medical device master file technical support
  • Product transfer to manufacturer, documentation and management
  • Design history file management and technical file creation