Design Input Document Control Matrix

In the FDA Regulations description of the Design Input Document Control Matrix is regarded to be a good mechanism to control design input documentation:

• By establishing a document that provides overall control to the design input process, firms provide the FDA with a good verification mechanism
• Include a checklist that identifies completed activities (in order to spot incomplete, ambigious or conflicting requirements)
• Elements that should be documented are:
  • The purpose oof the device and its intended use
  • A description or theory of operation
  • Components of the device
  • Operational modes
  • Prelimairy Risk Analysis
  • Controls and alarms
  • Interfaces or connectors
  • Standards or applicable regulations
  • Performance or reliability specifications
  • Environmental specifications
  • Physical specificatsions
  • Safety specifications
  • Master verification plan and master validatio pan
  • Preliminairy labels and labeling