Quality System Regulation

July 22, 2016 8:45am

What is it about?

  • Statutory requirements
  • The seven subsystems of the Quality Systems Regulation
    • Management Controls
    • Corrective Action and Preventive Action
    • Design Controls
    • Production and Process Controls
    • Materials Controls
      • supplier quality and design issues
      • third-party supplier programs
    • Facilities
    • Document Controls
  • Quality Systems Inspection Technique (QSIT)
  • Voluntary ISO 13485 Inspection Program
  • International Medical Device Regulators Forum (IMDRF)

Session Materials