Quality / Manufacturing / Validation

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

  • Design and Development (Planning, Input, Output, Review, Verification, Validation, Transfer)
  • Risk Management
  • Usability Engineering
  • Product Software
  • Device Labeling
  • Validation of Processes for Production and Service Provision
  • Identification and Tractability
  • Quality Audits