Design verification and validation activities

In CFR 21-820.30f - Design Verification and CFR 21-820.30g - Design Validation. Design verification activities include the following:

• Verification training by the design team
• Pretesting review that consists of a complete and thorough review of the following:
  • Design inputs or requirements
  • Design outputs or specifications
  • Assessments to ensure that the design output or specifications meet the design input or requirements
  • Risk analysis and control of identified individual hazards
  • All labelling against requirements, specifications and risk analysis including documentaion risk or hazards
• Master Verification Plan including the following:
  • Verification criteria
  • Verification assumptions and expectations
  • Verification personnel, their qualifications and responsibilities
• Appropriate testing of the following:
  • Individual parts elements, components, modules, software components
  • All inputs under normal, abnormal and absurd conditions
  • Testing deviations or failures
  • Deviations or failures after approprate corrective actions
• Equipment calibrated with test equipment and controlled with appropriate requirements
• Master verification and test plans should do the following:
  • Consider any Premarket notification documetation requirements
  • Perform according to written and approved master verification plan and test plans
  • Ensure identified risks or hazards are fully tested via written test plans
• Documentation that verifies design review and appropriate testing
  • Identification of the device
  • Methods used in the verification
  • Dates
  • Individuals performing the verification
  • All verification documentation should be considered Controlled Documentation
• Verification review in which appriopriate individuals review and approve all verifictaion activities, including master verification plan, test plans, test results and any retesting after corrective actions or changes.