Development

Product Development Process

Evergreen Medical will refine the concept(s) to the point where concepts are ready to be tested against the design inputs. Such activities usually include bench and animal testing. This may involve multiple design and process iterations as well as the creation and finalization of the instructions for use, product labeling and packaging (ready for testing).

Key activities include:

  • Establishment of the design history file (DHF)
  • Definition of design outputs
  • Risk and hazards analysis
  • Process refinement (equipment development)
  • Test system development
  • Determination of final detailed design based on:
    • Bench and animal testing (as applicable)
    • Completion of all drawings and specifications
    • Manufacturing and development cost targets
    • Packaging configuration
    • Labeling and instructions for use
  • Complete & submit regulatory documentation
  • Implement Clinical Studies (as applicable)