Quality Systems Regulation and UDI

July 28, 2017 9:30am

Tricia Kaufman
Of Counsel
Stinson Leonard Street LLP (Minneapolis, MN)

Brian Malkin
Counsel
Arent Fox LLP (Washington, DC)

  • 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)
  • Determining whether a device is subject to UDI
  • Software and other “virtual” devices
  • Update on Class 2 compliance
  • How to reshape systemic activities within your organization in order to comply with UDI requirements